CancerFemFertilAYANCT07622420
ProspectiveFemaleAYA - Late Effects of Cancer Therapies on Gonadal Function, Fertility, Efficiency of Fertility Preservation Procedures and Pregnancy Outcomes
An observational study of Cancer and Cancer in Pregnancy, run by Karolinska Institutet.
Trial summary
In the past two decades, the evidence-based knowledge on the prevalence and risk factors for gonads impairment, including infertility, following cancer and numerous cancer treatment regimen has significantly increased. Read more about this study
- Who is it for?
- Ages 15 to 39 years, women only
- Conditions the study is for
- Cancer, Cancer in Pregnancy, Infertility
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 May 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 39 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Multi-center prospective cohort study of females presenting with and treated for AYA cancers at age 15-39
Who may be able to join
- Female cancer patients aged between 15 and 39 years at diagnosis.
- Receiving a diagnosis of primary cancer 01/01/2025 or later
- Treated with chemotherapy and/or targeted therapy/immunotherapy and/or radiotherapy/ radioactive iodine therapy and/or gynaecological surgery.
- Detailed information on treatment received available.
Who cannot join
- Pre-existing known POI at cancer diagnosis.
- Treated by surgery alone (except gynaecological surgery).
- Patients with relapse or secondary malignant neoplasms at time of inclusion or having received already treatments for cancer
- Adult individuals subject of a measure of legal protection and/or patients with severe mental disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Late Effects of Cancer Therapies on Gonadal Function, Fertility, Efficiency of Fertility Preservation Procedures and Pregnancy Outcomes (ProspectiveFemaleAYA)
In the past two decades, the evidence-based knowledge on the prevalence and risk factors for gonads impairment, including infertility, following cancer and numerous cancer treatment regimen has significantly increased. However, data remains mostly insufficient for individualized prediction of (future) fertility and pregnancy potential, including the use and success of artificial reproductive technologies (ART). Furthermore, therapies have become increasingly complex as more recent treatment regimen have continuously also implemented novel treatment approaches (e.g. immune therapies such as checkpoint inhibitors) for which no comprehensive data regarding its impact on fertility and pregnancy outcomes is available, yet.
It is crucial to carefully balance risk-benefit between fertility preservation (FP) procedures and potential of gonadal function/fertility impairment, to examine the efficiency and safety, as well as to assess patients' satisfaction regarding the FP procedures. Answering these questionsis highly relevant as it has been shown that fertility capacity and post-treatment gonadal function may represent a significant part of quality of life in young cancer survivors.
Read more
The study therefore aim to set up a large-scale registry of emerging data collection programmes to evaluate the gonadotoxic risks, including the prevalence and course of ovarian dysfunction and/or fertility impairment and premature ovarian insufficiency following specific treatments, identification of further risk factors and predictive markers to enhance precision survivorship research in this field. Additionally, data on the use of fertility preservation/hormonal treatment and patients' satisfaction related to these procedures in Europe will be analysed to support patient-centric care.
Reproductive health counselling should not be limited to evaluating the risk of gonadotoxicity and offering fertility preservation to those at risk. It should also include evaluating the impact on post-treatment sexuality, menopausal symptoms management, and the counselling on contraception.
In addition to clinical information, whole genome sequence data will be generated for selected study participants with evidence of varying impact of gonadotoxic therapies on reproductive function to find genetic variants associated with risk of reproductive and organ toxicity.
The data collection will focus on all different cancer diseases, including diseases which are less common such as different types of sarcomas. This will be a significant development to the current state of information in existing registries.
The primary objectives of this prospective analysis of European ongoing adolescent and young adult (AYA) cancer patient cohorts are:
- To establish a database with relevant clinical characteristics at time of diagnosis, cancer therapy received and post-cancer clinical and reproductive outcomes by following AYA cancer patients longitudinally.
- To evaluate the effect of cancer therapies on ovarian function and reproductive potential.
- To evaluate fertility preservation measures performed, their risks and efficacy.
- To evaluate the impact of fertility preservation measures on the risk of cancer relapse.
- To evaluate occurrence of pregnancies/live births naturally conceived (including unplanned) or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue.
- To set up a genetic database based on whole genome sequencing of AYAs of the cohort. For this objective a Substudy 1 : " Development of risk prediction models based on clinical and genetic data " will be conducted.
- To develop prediction models for organ toxicities in cancer patients (objective included in Substudy 1).
- To evaluate the effect of cancer therapies on sexuality and quality of life. For this objective a Substudy 2 : "Sexual Health" will be conducted.
- To evaluate the use and counselling on contraception. For this objective, a Substudy 3 : "Contraception" will be conducted.
- To describe management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms. For this objective a Substudy 4 "Management of POI and Menopause Symptoms" will be conducted.
- To explore patient's satisfaction receiving counseling and/or undergoing fertility preservation. For this objective a Substudy 5 on "Satisfaction with Fertility Preservation" will be conducted.
Read the detailed description
Fertility preservation (FP) and fertility counselling at the time of diagnosis and throughout follow-up are recommended to improve the quality of life of young patients diagnosed with cancer. It has been shown that gonadal function, as well as fertility capacity after treatment are crucial aspects for AYA cancer survivors . While natural conception can be possible after cancer treatment, cancer-treatment related risk factors for impaired fertility, including a drastically reduced reproductive window, have been identified.
The impact of gonadototoxic medications might also be related to genetic factors. Data on gonadotoxicity have revealed a high variance in the effect of cancer therapies on gonadal and organ function irrespective of the kind of drugs used and dosage. The high variance indicates individual risks which might be related to specific genetic variants. To better counsel on the risk of infertility and to better indicate fertility preservation (FP) measures, it would be beneficial to identify such genetic factors to develop a genetic prediction model.
FP techniques are progressing rapidly and have demonstrated their effectiveness in terms of pregnancy chances and live-birth rates. However, it remains difficult to elaborate firm and evidence-based FP strategies according to a patient's individual factors and cancer treatment. In addition, it remains crucial to carefully balance the risk-benefit of FP procedures and the potential of ovarian/fertility impairment, to examine the efficiency and safety of FP procedures and pregnancies as well as to assess patients' satisfaction regarding FP procedures. Large scale prospective and systematic short- and long-term data on the impact of specific cancer therapies on fertility based on fertility parameters such as ovarian reserve markers, sperm quality and pregnancies hardly exist. Specialized centres and joint regional and national network initiatives have started collecting such data. However, even though these initiatives are of great value and are sufficient to generate data from common cancer diseases such as breast cancer, rare cancers as well as on novel therapeutics (e.g. anti-VEGF or immune therapies) and more complex cancer treatment regimens require large scale data collection initiatives to gain in-depth robust data for appropriate individual fertility-related counselling of female and male AYA patients.
Ovarian reserve markers such as serum AMH level variations may be a direct and real-time indicator of follicular depletion and recovery during and after cancer treatment, as well as it is a non-invasive and reproducible marker. Systematic follow-up of AMH has been suggested in AYA patients with at least a measurement at baseline and within the 2 years following the end of gonadotoxic treatment. In parallel, the menstrual function pattern should be regularly analysed as a relevant clinical surrogate and independent variable to determine prevalence of cancer treatment-induced amenorrhea, its duration and hormonal and clinical signs of potential post treatment premature ovarian insufficiency (POI).
The ProspectiveFemaleAYA (FemFertilAYA) study within the PredictAYA project, therefore aim to set up a large-scale network structure of previously established data collection programs in specialized centres/networks to evaluate the ovarian toxicity, the prevalence of impaired ovarian function, its course and/or fertility impairment, POI following specific treatments, and identification of predictive markers. Furthermore, data on the use of FP and/or subsequent use of artificial reproductive treatment (ART) as well as patients' satisfaction related to these procedures in Europe will drive the understanding of patient-centered care.
A genetic database based on whole genome sequencing of selected females with evidence of impact of gonadotoxic therapies on ovarian function below and above average will be set up to identify genetic variants associated with individual risk of reproductive and organ toxicities. Whole genome sequence (WGS) data will provide an opportunity to identify and test potential genetic variants (and biomarkers) associated with chemotherapy-induced ovarian toxicity. The study will rely on WGS data and matching clinical information to develop statistical prediction models for female reproductive toxicities, as well as other toxicities when feasible. To this end, the study will systematically investigate the relationship between common genetic variation and clinically observed reproductive, cardiac, neurological, or systemic toxicities. ProspectiveFemaleAYA will identify genes and pathways that are enriched for variants associated with acquired ovarian toxicity with special focus on known pathways related to metabolism of cytotoxic drugs, DNA damage response (DDR), and other known toxicity outcome related processes as well as enrichment in other networks or pathways. Using SNVs below a data-driven minimum for the false discovery rate, will identify genes (using Burden tests) and pathways that are enriched for variants associated with the gonadal toxicity phenotypes. To further refine the variants of interest, cross-validation of SNVs will be applied and the classification technique called "random LASSO" alongside gene regulatory networks (GRNs). Machine learning modelling will be employed to propose oligo- or polygenic risk models for predicting the genotoxic effects of cancer therapy on future fertility. These data will provide a robust foundation for investigating the biological mechanisms of chemotherapy-induced gonadal toxicity and development of prediction models, enabling future targeted interventions and personalized medicine approaches to mitigate adverse effects on reproductive health.
Post-treatment sexuality, contraception and management of potential menopausal symptoms are additional relevant topics that should be addressed in counselling of patients living with and beyond cancer. ProspectiveFemaleAYA we prospectively assess both, post-treatment sexuality and contraception, in two separate sub-cohorts of patients. Additionally, the study will investigate clinical practices on menopausal symptoms management, which can significantly influence sexual dysfunction by questionnaires to the physicians.
Sexual dysfunction in any phase of the sexual response cycle, from arousal to orgasm, is widely under addressed in cancer survivors, despite being a common late effect of cancer. Experiencing sexual dysfunction following cancer may be attributable to a single cause but usually is an interplay of somatic (e.g. pelvic dysfunction), psychological (e.g. body image, reduced libido, but also depression, anxiety) and social (new roles in partnership, financial burden) factors. Literature estimates that it occurs in up to 50% of young adult cancer survivors. Despite the relevance of the issue, patients self-reported, that sexual health (SH) is rarely discussed during oncological follow ups and literature lacks in regard to the actual prevalence in the different types of cancers and protective/risk factors. In this context, the role of the oncofertility unit is shifting from an urgent pre-therapies counselling focusing only on fertility preservation procedure to a broader approach that encompasses various aspects of reproductive and sexual life.
Among these aspects, treatment-induced premature ovarian insufficiency (POI) is frequently accompanied by early menopausal symptoms with substantial impact on quality of life and long-term health outcomes. Although it has been established that hormone replacement therapy (HRT) is safe in most cancers, with few exceptions, management strategies remain variable across institutions, reflecting limited data on real-world clinical practice. For this reason, evaluating current approaches to POI and menopausal symptom management is essential to identify unmet needs and promote harmonized care pathways.
Given that a cancer diagnosis does not always coincide with the loss of reproductive function, it is also crucial to ensure cancer survivors receive complete counselling regarding safe and effective contraception options to avoid unplanned pregnancies. However, the published literature shows a suboptimal contraception use both during and after cancer treatments and an increased risk of unwanted pregnancies in these women. This concern will be also addressed in this prospective cohort. As safety of pregnancies is also related to other organ functions, counselling should, if possible, also include further health factors such as organ toxicity which might have an impact on safety of pregnancies.
The registry will focus on all different cancer diseases, including diseases which are less common such as different types of sarcoma. This will be a significant difference from other registries. By capping the number of patients per disease, it will be possible to include a sufficient number of cases of less common diseases, as the cost reimbursement quota per data record is limited.
- Conditions
- Cancer, Cancer in Pregnancy, Infertility, In Vitro Fertilisation (IVF) Treatment, Late Effects, Quality of Life
- Keywords
- cancer therapy induced late effects, AYA cancer survivors, infertility as a late effect of cancer, late effects prediction
- Medical subject headings
- Neoplasms, Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Constitution of the RedCap database
RecCap database including all study parameters for data harmonisation and centralized access.
Measured: June 2030
Genetic database based on whole genome sequencing of AYAs
Data base including Whole-genome sequencing data.
Measured: June 2030
The impact of fertility preservation measures on the risk of cancer relapse.
Cancer relapse rates in relation to fertility preservation measures performed.
Measured: June 2030
Develop prediction models for organ toxicities in cancer patients.
Development of multimodal prediction models for chemotherapy induced effects on AMH levels, AFC, menses pattern pre-post cancer treatment in relation to cancer diagnosis and therapy.
Measured: June 2030
Effect of cancer type on sexuality and quality of life (1).
Exploring sexual health and QOL using validated EORTC questionnaires.
EORTC-SH22 total scores (adjusted for relevant predictors) in patients who had their first consultation with the oncofertility unit before therapies versus those who had not.
Measured: June 2030
Effect of cancer type on sexuality and quality of life (2).
Exploring sexual health and QOL using validated EORTC questionnaires. EORTC-SH22 total scores stratified for type of cancer and type of treatment used.
Measured: June 2030
Effect of cancer type on sexuality and quality of life (3).
Exploring sexual health and QOL using validated EORTC questionnaires.
EORTC-SH22 total scores in survivors of cancer traditionally considered highly impactful on sexual health (breast, gynecological, rectum) versus others.
Measured: June 2030
Effect of cancer type on sexuality and quality of life (4).
Exploring sexual health and QOL using validated EORTC questionnaires.
EORTC-SH22 scores if contraception use (Y/N) and HRT use (Y/N).
Measured: June 2030
Effect of cancer type on sexuality and quality of life (5).
Exploring sexual health and QOL using validated EORTC questionnaires.
EORTC-SH22 question 11 results (communication with healthcare professionals) to patients' characteristics (age, disease, treatment, time from diagnosis, …).
Measured: June 2030
Effect of cancer type on sexuality and quality of life (6).
Exploring sexual health and QOL using validated EORTC questionnaires.
Correlation between EORTC-SH22 total scores and EORTC-QLQ-C30 scores.
Measured: June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (1).
Menses pattern pre-post cancer treatment in relation to cancer therapy.
Measured: June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (2).
Menses pattern pre-post cancer treatment in relation to cancer diagnosis.
Measured: June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (3).
AFC pre-post cancer treatment in relation to cancer therapy.
Measured: June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (4).
AFC pre-post cancer treatment in relation to cancer diagnosis.
Measured: June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (5).
AMH levels pre-post cancer treatment in relation to cancer therapy.
Measured: June 2030
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (6).
AMH levels pre-post cancer treatment in relation to cancer diagnosis.
Measured: June 2030
The use of contraception during and after treatment (1).
Longitudinal use of contraception during and after treatment compared to general population
Measured: June 2030
The use of contraception during and after treatment (2).
Type of contraceptive used during and after treatment compared to general population
Measured: June 2030
The use of contraception during and after treatment (3).
Type of contraception according to diseases
Measured: June 2030
The use of contraception during and after treatment (4).
Use of contraception type according to patients' characteristics
Measured: June 2030
The use of contraception during and after treatment (5).
Association of unexpected pregnancies and contraception access (EPF ranking scale https://www.epfweb.org/node/89); Contraception counseling and satisfaction (anonymous survey).
Measured: June 2030
The use of contraception during and after treatment (6).
Occurrence of unplanned pregnancies according to patients' characteristics
Measured: June 2030
The use of contraception during and after treatment (7).
Occurrence of unplanned pregnancies according to patients' diseases.
Measured: June 2030
The use of contraception during and after treatment (8).
Occurrence of unplanned pregnancies according to patients' fertility preservation strategies
Measured: June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (1).
Association between FP performed and subsequent risk.
Risk defined as: Bleeding, infection, thrombosis, postponement of cancer therapies for >1 week.
Measured: June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (2).
Association between Oocyte freezing with ovarian stimulation and risk.
Measured: June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (3).
Association between oocyte freezing without ovarian stimulation and subsequent Risk.
Measured: June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (4).
Association between ovarian tissue freezing (surgical technique) and subsequent risk
Measured: June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (5).
Association between GnRH analogues (agonists, antagonists) and risk
Measured: June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (6).
Measures performed: Oocyte freezing with ovarian stimulation
Association between FP measure performed and number of oocytes cryopreserved
Measured: June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (7).
Measures performed: oocyte freezing without ovarian stimulation
Association between FP performed and number of oocytes cryopreserved
Measured: June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (8).
Measures performed: ovarian tissue freezing (surgical technique)
Association between FP measured performed and amount of tissue cryopreserved.
Measured: June 2030
Evaluate fertility preservation measures performed, their risks and efficacy (9).
Measures performed: GnRH analogues (agonists, antagonists)
Association between FP performed and AMH recovery
Measured: June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (1).
Spontaneous pregnancy rates.
Measured: June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (2)
Spontaneous live birth rates.
Measured: June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (3).
Pregnancy rates using oocytes
Measured: June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (4).
Live birth rates using oocytes.
Measured: M60
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (5).
Pregnancy rates using ovarian tissue.
Measured: June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (6).
Live birth rates using ovarian tissue.
Measured: June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (7).
Pregnancy rates associated to technique of thawing cycles and tissue transplantation.
Measured: June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (8).
Live birth rates associated to technique of thawing cycles and tissue transplantation.
Measured: June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (9).
obstetrical complications following the use of cryopreserved oocytes
Measured: June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (10).
neonatal health following the use of cryopreserved oocytes
Measured: June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (11).
neonatal health following the use of cryopreserved oocytes
Measured: June 2030
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (12).
neonatal health following the use of gonadal tissue
Measured: June 2030
Secondary outcomes (14)
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (1).
Frequency of menopausal symptom-related consultations
Measured: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (2).
type of symptom clusters driving care requests
Measured: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (3).
Use of routine symptom screening in follow-up
Measured: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (4).
Ancillary investigations routinely performed (bone health, cardiovascular risk, sexual health, etc.)
Measured: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (5).
Prescribing frequency and modality
Measured: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (6).
Clinicians' perceived acceptability/safety of systemic and vaginal hormonal therapies across cancer types
Measured: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (7).
Reported real-world use of hormonal therapies by cancer type
Measured: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (8).
Discordance between beliefs and practice and underlying reasons
Measured: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (9).
Patient acceptance rates and reasons for refusal
Measured: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (10).
Structure of care pathways and leading specialty key barriers and priorities for improvement in menopause care delivery
Measured: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (11).
Occurrence of menopausal symptoms reported in the prospective cohort according to patient's characteristics and disease and type of HRT or treatment.
Measured: June 2030
Access and barriers to reproductive counselling and FP, and evaluate satisfaction with these programs across Europe (1).
Anonymous surveys to capture satisfaction with fertility preservation among AYA cancer survivors. Map access to FP proceedures across the participating countries.
Measured: June 2028
Access and barriers to reproductive counselling and FP, and evaluate satisfaction with these programs across Europe (2).
Available procedures and service gaps will be examined through semi structured qualitative interviews conducted among a select group to capture the lived experiences of fertility preservation decision making in further depth.
Measured: June 2028
Access and barriers to reproductive counselling and FP, and evaluate satisfaction with these programs across Europe (3).
Patients unmet needs will be examined through semi structured qualitative interviews conducted among a select group to capture the lived experiences of fertility preservation unmet needs in further depth.
Measured: June 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, University of Bern, Institut National de la Santé Et de la Recherche Médicale, France, University of Leipzig, Université Libre de Bruxelles, Ospedale Policlinico San Martino, Linkoeping University, University of Tartu, University Hospital Heidelberg, Medical University Innsbruck, University of Edinburgh, Hospital Clínico Universitario de Valencia, Careggi Hospital, University of Genova, Vrije Universiteit Brussel, Aix Marseille Université, Centre Leon Berard, Istituto Europeo di Oncologia, European Union, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Institute of Oncology Ljubljana, University Hospital, Angers, Hopital Antoine Beclere, Universitair Ziekenhuis Brussel
- Responsible party
- Principal investigator, Kenny Rodriguez-Wallberg, Karolinska Institutet
- Investigators
- Kenny A Rodriguez-Wallberg, Prof. MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622420
- Sponsor's protocol ID
- V1-08/03/2026
- Other IDs
- 101214879
- Acronym
- FemFertilAYA
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Effects of Cancer Therapies on Gonadal Function, Fertility, Efficiency of Fertility Preservation Procedures and Pregnancy Outcomes (ProspectiveFemaleAYA)
- ClinicalTrials.gov ID
- NCT07622420
- Acronym / sponsor ID
- FemFertilAYA / V1-08/03/2026
- Conditions
- Cancer, Cancer in Pregnancy, Infertility, In Vitro Fertilisation (IVF) Treatment, Late Effects, Quality of Life
- Keywords
- cancer therapy induced late effects, AYA cancer survivors, infertility as a late effect of cancer, late effects prediction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, University of Bern, Institut National de la Santé Et de la Recherche Médicale, France, University of Leipzig, Université Libre de Bruxelles, Ospedale Policlinico San Martino, Linkoeping University, University of Tartu, University Hospital Heidelberg, Medical University Innsbruck, University of Edinburgh, Hospital Clínico Universitario de Valencia, Careggi Hospital, University of Genova, Vrije Universiteit Brussel, Aix Marseille Université, Centre Leon Berard, Istituto Europeo di Oncologia, European Union, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Institute of Oncology Ljubljana, University Hospital, Angers, Hopital Antoine Beclere, Universitair Ziekenhuis Brussel
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2035 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the past two decades, the evidence-based knowledge on the prevalence and risk factors for gonads impairment, including infertility, following cancer and numerous cancer treatment regimen has significantly increased. However, data remains mostly insufficient for individualized prediction of (future) fertility and pregnancy potential, including the use and success of artificial reproductive technologies (ART). Furthermore, therapies have become increasingly complex as more recent treatment regimen have continuously also implemented novel treatment approaches (e.g. immune therapies such as checkpoint inhibitors) for which no comprehensive data regarding its impact on fertility and pregnancy outcomes is available, yet.
It is crucial to carefully balance risk-benefit between fertility preservation (FP) procedures and potential of gonadal function/fertility impairment, to examine the efficiency and safety, as well as to assess patients' satisfaction regarding the FP procedures. Answering these questionsis highly relevant as it has been shown that fertility capacity and post-treatment gonadal function may represent a significant part of quality of life in young cancer survivors.
The study therefore aim to set up a large-scale registry of emerging data collection programmes to evaluate the gonadotoxic risks, including the prevalence and course of ovarian dysfunction and/or fertility impairment and premature ovarian insufficiency following specific treatments, identification of further risk factors and predictive markers to enhance precision survivorship research in this field. Additionally, data on the use of fertility preservation/hormonal treatment and patients' satisfaction related to these procedures in Europe will be analysed to support patient-centric care.
Reproductive health counselling should not be limited to evaluating the risk of gonadotoxicity and offering fertility preservation to those at risk. It should also include evaluating the impact on post-treatment sexuality, menopausal symptoms management, and the counselling on contraception.
In addition to clinical information, whole genome sequence data will be generated for selected study participants with evidence of varying impact of gonadotoxic therapies on reproductive function to find genetic variants associated with risk of reproductive and organ toxicity.
The data collection will focus on all different cancer diseases, including diseases which are less common such as different types of sarcomas. This will be a significant development to the current state of information in existing registries.
The primary objectives of this prospective analysis of European ongoing adolescent and young adult (AYA) cancer patient cohorts are:
- To establish a database with relevant clinical characteristics at time of diagnosis, cancer therapy received and post-cancer clinical and reproductive outcomes by following AYA cancer patients longitudinally.
- To evaluate the effect of cancer therapies on ovarian function and reproductive potential.
- To evaluate fertility preservation measures performed, their risks and efficacy.
- To evaluate the impact of fertility preservation measures on the risk of cancer relapse.
- To evaluate occurrence of pregnancies/live births naturally conceived (including unplanned) or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue.
- To set up a genetic database based on whole genome sequencing of AYAs of the cohort. For this objective a Substudy 1 : " Development of risk prediction models based on clinical and genetic data " will be conducted.
- To develop prediction models for organ toxicities in cancer patients (objective included in Substudy 1).
- To evaluate the effect of cancer therapies on sexuality and quality of life. For this objective a Substudy 2 : "Sexual Health" will be conducted.
- To evaluate the use and counselling on contraception. For this objective, a Substudy 3 : "Contraception" will be conducted.
- To describe management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms. For this objective a Substudy 4 "Management of POI and Menopause Symptoms" will be conducted.
- To explore patient's satisfaction receiving counseling and/or undergoing fertility preservation. For this objective a Substudy 5 on "Satisfaction with Fertility Preservation" will be conducted.
Detailed description
Fertility preservation (FP) and fertility counselling at the time of diagnosis and throughout follow-up are recommended to improve the quality of life of young patients diagnosed with cancer. It has been shown that gonadal function, as well as fertility capacity after treatment are crucial aspects for AYA cancer survivors . While natural conception can be possible after cancer treatment, cancer-treatment related risk factors for impaired fertility, including a drastically reduced reproductive window, have been identified.
The impact of gonadototoxic medications might also be related to genetic factors. Data on gonadotoxicity have revealed a high variance in the effect of cancer therapies on gonadal and organ function irrespective of the kind of drugs used and dosage. The high variance indicates individual risks which might be related to specific genetic variants. To better counsel on the risk of infertility and to better indicate fertility preservation (FP) measures, it would be beneficial to identify such genetic factors to develop a genetic prediction model.
FP techniques are progressing rapidly and have demonstrated their effectiveness in terms of pregnancy chances and live-birth rates. However, it remains difficult to elaborate firm and evidence-based FP strategies according to a patient's individual factors and cancer treatment. In addition, it remains crucial to carefully balance the risk-benefit of FP procedures and the potential of ovarian/fertility impairment, to examine the efficiency and safety of FP procedures and pregnancies as well as to assess patients' satisfaction regarding FP procedures. Large scale prospective and systematic short- and long-term data on the impact of specific cancer therapies on fertility based on fertility parameters such as ovarian reserve markers, sperm quality and pregnancies hardly exist. Specialized centres and joint regional and national network initiatives have started collecting such data. However, even though these initiatives are of great value and are sufficient to generate data from common cancer diseases such as breast cancer, rare cancers as well as on novel therapeutics (e.g. anti-VEGF or immune therapies) and more complex cancer treatment regimens require large scale data collection initiatives to gain in-depth robust data for appropriate individual fertility-related counselling of female and male AYA patients.
Ovarian reserve markers such as serum AMH level variations may be a direct and real-time indicator of follicular depletion and recovery during and after cancer treatment, as well as it is a non-invasive and reproducible marker. Systematic follow-up of AMH has been suggested in AYA patients with at least a measurement at baseline and within the 2 years following the end of gonadotoxic treatment. In parallel, the menstrual function pattern should be regularly analysed as a relevant clinical surrogate and independent variable to determine prevalence of cancer treatment-induced amenorrhea, its duration and hormonal and clinical signs of potential post treatment premature ovarian insufficiency (POI).
The ProspectiveFemaleAYA (FemFertilAYA) study within the PredictAYA project, therefore aim to set up a large-scale network structure of previously established data collection programs in specialized centres/networks to evaluate the ovarian toxicity, the prevalence of impaired ovarian function, its course and/or fertility impairment, POI following specific treatments, and identification of predictive markers. Furthermore, data on the use of FP and/or subsequent use of artificial reproductive treatment (ART) as well as patients' satisfaction related to these procedures in Europe will drive the understanding of patient-centered care.
A genetic database based on whole genome sequencing of selected females with evidence of impact of gonadotoxic therapies on ovarian function below and above average will be set up to identify genetic variants associated with individual risk of reproductive and organ toxicities. Whole genome sequence (WGS) data will provide an opportunity to identify and test potential genetic variants (and biomarkers) associated with chemotherapy-induced ovarian toxicity. The study will rely on WGS data and matching clinical information to develop statistical prediction models for female reproductive toxicities, as well as other toxicities when feasible. To this end, the study will systematically investigate the relationship between common genetic variation and clinically observed reproductive, cardiac, neurological, or systemic toxicities. ProspectiveFemaleAYA will identify genes and pathways that are enriched for variants associated with acquired ovarian toxicity with special focus on known pathways related to metabolism of cytotoxic drugs, DNA damage response (DDR), and other known toxicity outcome related processes as well as enrichment in other networks or pathways. Using SNVs below a data-driven minimum for the false discovery rate, will identify genes (using Burden tests) and pathways that are enriched for variants associated with the gonadal toxicity phenotypes. To further refine the variants of interest, cross-validation of SNVs will be applied and the classification technique called "random LASSO" alongside gene regulatory networks (GRNs). Machine learning modelling will be employed to propose oligo- or polygenic risk models for predicting the genotoxic effects of cancer therapy on future fertility. These data will provide a robust foundation for investigating the biological mechanisms of chemotherapy-induced gonadal toxicity and development of prediction models, enabling future targeted interventions and personalized medicine approaches to mitigate adverse effects on reproductive health.
Post-treatment sexuality, contraception and management of potential menopausal symptoms are additional relevant topics that should be addressed in counselling of patients living with and beyond cancer. ProspectiveFemaleAYA we prospectively assess both, post-treatment sexuality and contraception, in two separate sub-cohorts of patients. Additionally, the study will investigate clinical practices on menopausal symptoms management, which can significantly influence sexual dysfunction by questionnaires to the physicians.
Sexual dysfunction in any phase of the sexual response cycle, from arousal to orgasm, is widely under addressed in cancer survivors, despite being a common late effect of cancer. Experiencing sexual dysfunction following cancer may be attributable to a single cause but usually is an interplay of somatic (e.g. pelvic dysfunction), psychological (e.g. body image, reduced libido, but also depression, anxiety) and social (new roles in partnership, financial burden) factors. Literature estimates that it occurs in up to 50% of young adult cancer survivors. Despite the relevance of the issue, patients self-reported, that sexual health (SH) is rarely discussed during oncological follow ups and literature lacks in regard to the actual prevalence in the different types of cancers and protective/risk factors. In this context, the role of the oncofertility unit is shifting from an urgent pre-therapies counselling focusing only on fertility preservation procedure to a broader approach that encompasses various aspects of reproductive and sexual life.
Among these aspects, treatment-induced premature ovarian insufficiency (POI) is frequently accompanied by early menopausal symptoms with substantial impact on quality of life and long-term health outcomes. Although it has been established that hormone replacement therapy (HRT) is safe in most cancers, with few exceptions, management strategies remain variable across institutions, reflecting limited data on real-world clinical practice. For this reason, evaluating current approaches to POI and menopausal symptom management is essential to identify unmet needs and promote harmonized care pathways.
Given that a cancer diagnosis does not always coincide with the loss of reproductive function, it is also crucial to ensure cancer survivors receive complete counselling regarding safe and effective contraception options to avoid unplanned pregnancies. However, the published literature shows a suboptimal contraception use both during and after cancer treatments and an increased risk of unwanted pregnancies in these women. This concern will be also addressed in this prospective cohort. As safety of pregnancies is also related to other organ functions, counselling should, if possible, also include further health factors such as organ toxicity which might have an impact on safety of pregnancies.
The registry will focus on all different cancer diseases, including diseases which are less common such as different types of sarcoma. This will be a significant difference from other registries. By capping the number of patients per disease, it will be possible to include a sufficient number of cases of less common diseases, as the cost reimbursement quota per data record is limited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Multi-center prospective cohort study of females presenting with and treated for AYA cancers at age 15-39
Key inclusion criteria (4 listed)
- Female cancer patients aged between 15 and 39 years at diagnosis.
- Receiving a diagnosis of primary cancer 01/01/2025 or later
- Treated with chemotherapy and/or targeted therapy/immunotherapy and/or radiotherapy/ radioactive iodine therapy and/or gynaecological surgery.
- Detailed information on treatment received available.
Key exclusion criteria (4 listed)
- Pre-existing known POI at cancer diagnosis.
- Treated by surgery alone (except gynaecological surgery).
- Patients with relapse or secondary malignant neoplasms at time of inclusion or having received already treatments for cancer
- Adult individuals subject of a measure of legal protection and/or patients with severe mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Constitution of the RedCap database
Time frame: June 2030
RecCap database including all study parameters for data harmonisation and centralized access.
Genetic database based on whole genome sequencing of AYAs
Time frame: June 2030
Data base including Whole-genome sequencing data.
The impact of fertility preservation measures on the risk of cancer relapse.
Time frame: June 2030
Cancer relapse rates in relation to fertility preservation measures performed.
Develop prediction models for organ toxicities in cancer patients.
Time frame: June 2030
Development of multimodal prediction models for chemotherapy induced effects on AMH levels, AFC, menses pattern pre-post cancer treatment in relation to cancer diagnosis and therapy.
Effect of cancer type on sexuality and quality of life (1).
Time frame: June 2030
Exploring sexual health and QOL using validated EORTC questionnaires. EORTC-SH22 total scores (adjusted for relevant predictors) in patients who had their first consultation with the oncofertility unit before therapies versus those who had not.
Effect of cancer type on sexuality and quality of life (2).
Time frame: June 2030
Exploring sexual health and QOL using validated EORTC questionnaires. EORTC-SH22 total scores stratified for type of cancer and type of treatment used.
Effect of cancer type on sexuality and quality of life (3).
Time frame: June 2030
Exploring sexual health and QOL using validated EORTC questionnaires. EORTC-SH22 total scores in survivors of cancer traditionally considered highly impactful on sexual health (breast, gynecological, rectum) versus others.
Effect of cancer type on sexuality and quality of life (4).
Time frame: June 2030
Exploring sexual health and QOL using validated EORTC questionnaires. EORTC-SH22 scores if contraception use (Y/N) and HRT use (Y/N).
Effect of cancer type on sexuality and quality of life (5).
Time frame: June 2030
Exploring sexual health and QOL using validated EORTC questionnaires. EORTC-SH22 question 11 results (communication with healthcare professionals) to patients' characteristics (age, disease, treatment, time from diagnosis, …).
Effect of cancer type on sexuality and quality of life (6).
Time frame: June 2030
Exploring sexual health and QOL using validated EORTC questionnaires. Correlation between EORTC-SH22 total scores and EORTC-QLQ-C30 scores.
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (1).
Time frame: June 2030
Menses pattern pre-post cancer treatment in relation to cancer therapy.
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (2).
Time frame: June 2030
Menses pattern pre-post cancer treatment in relation to cancer diagnosis.
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (3).
Time frame: June 2030
AFC pre-post cancer treatment in relation to cancer therapy.
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (4).
Time frame: June 2030
AFC pre-post cancer treatment in relation to cancer diagnosis.
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (5).
Time frame: June 2030
AMH levels pre-post cancer treatment in relation to cancer therapy.
Evaluate the effect of cancer therapies on ovarian function and reproductive potential (6).
Time frame: June 2030
AMH levels pre-post cancer treatment in relation to cancer diagnosis.
The use of contraception during and after treatment (1).
Time frame: June 2030
Longitudinal use of contraception during and after treatment compared to general population
The use of contraception during and after treatment (2).
Time frame: June 2030
Type of contraceptive used during and after treatment compared to general population
The use of contraception during and after treatment (3).
Time frame: June 2030
Type of contraception according to diseases
The use of contraception during and after treatment (4).
Time frame: June 2030
Use of contraception type according to patients' characteristics
The use of contraception during and after treatment (5).
Time frame: June 2030
Association of unexpected pregnancies and contraception access (EPF ranking scale https://www.epfweb.org/node/89); Contraception counseling and satisfaction (anonymous survey).
The use of contraception during and after treatment (6).
Time frame: June 2030
Occurrence of unplanned pregnancies according to patients' characteristics
The use of contraception during and after treatment (7).
Time frame: June 2030
Occurrence of unplanned pregnancies according to patients' diseases.
The use of contraception during and after treatment (8).
Time frame: June 2030
Occurrence of unplanned pregnancies according to patients' fertility preservation strategies
Evaluate fertility preservation measures performed, their risks and efficacy (1).
Time frame: June 2030
Association between FP performed and subsequent risk. Risk defined as: Bleeding, infection, thrombosis, postponement of cancer therapies for >1 week.
Evaluate fertility preservation measures performed, their risks and efficacy (2).
Time frame: June 2030
Association between Oocyte freezing with ovarian stimulation and risk.
Evaluate fertility preservation measures performed, their risks and efficacy (3).
Time frame: June 2030
Association between oocyte freezing without ovarian stimulation and subsequent Risk.
Evaluate fertility preservation measures performed, their risks and efficacy (4).
Time frame: June 2030
Association between ovarian tissue freezing (surgical technique) and subsequent risk
Evaluate fertility preservation measures performed, their risks and efficacy (5).
Time frame: June 2030
Association between GnRH analogues (agonists, antagonists) and risk
Evaluate fertility preservation measures performed, their risks and efficacy (6).
Time frame: June 2030
Measures performed: Oocyte freezing with ovarian stimulation Association between FP measure performed and number of oocytes cryopreserved
Evaluate fertility preservation measures performed, their risks and efficacy (7).
Time frame: June 2030
Measures performed: oocyte freezing without ovarian stimulation Association between FP performed and number of oocytes cryopreserved
Evaluate fertility preservation measures performed, their risks and efficacy (8).
Time frame: June 2030
Measures performed: ovarian tissue freezing (surgical technique) Association between FP measured performed and amount of tissue cryopreserved.
Evaluate fertility preservation measures performed, their risks and efficacy (9).
Time frame: June 2030
Measures performed: GnRH analogues (agonists, antagonists) Association between FP performed and AMH recovery
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (1).
Time frame: June 2030
Spontaneous pregnancy rates.
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (2)
Time frame: June 2030
Spontaneous live birth rates.
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (3).
Time frame: June 2030
Pregnancy rates using oocytes
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (4).
Time frame: M60
Live birth rates using oocytes.
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (5).
Time frame: June 2030
Pregnancy rates using ovarian tissue.
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (6).
Time frame: June 2030
Live birth rates using ovarian tissue.
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (7).
Time frame: June 2030
Pregnancy rates associated to technique of thawing cycles and tissue transplantation.
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (8).
Time frame: June 2030
Live birth rates associated to technique of thawing cycles and tissue transplantation.
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (9).
Time frame: June 2030
obstetrical complications following the use of cryopreserved oocytes
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (10).
Time frame: June 2030
neonatal health following the use of cryopreserved oocytes
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (11).
Time frame: June 2030
neonatal health following the use of cryopreserved oocytes
Occurrence of pregnancies/live births naturally conceived or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue (12).
Time frame: June 2030
neonatal health following the use of gonadal tissue
14 secondary outcomes
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (1).
Time frame: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (2).
Time frame: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (3).
Time frame: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (4).
Time frame: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (5).
Time frame: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (6).
Time frame: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (7).
Time frame: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (8).
Time frame: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (9).
Time frame: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (10).
Time frame: June 2030
Current clinical practices, prescribing patterns, and care pathways for management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms in female adolescent and young adult (AYA) cancer survivors (11).
Time frame: June 2030
Access and barriers to reproductive counselling and FP, and evaluate satisfaction with these programs across Europe (1).
Time frame: June 2028
Access and barriers to reproductive counselling and FP, and evaluate satisfaction with these programs across Europe (2).
Time frame: June 2028
Access and barriers to reproductive counselling and FP, and evaluate satisfaction with these programs across Europe (3).
Time frame: June 2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenny A Rodriguez-Wallberg, Prof. MD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cancer in Pregnancy, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenny A Rodriguez-Wallberg, Prof.MD (+46852481213, kenny.rodriguez-wallberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constitution of the RedCap database (time frame: June 2030). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.