InfertilityNCT04602962
Efficacy and Safety of Fertility Treatments and Fertility Preservation
An observational study of Infertility, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study analyses clinical data prospectively collected for over a decade in several clinical databases. Electronic medical records are available since 1998. Since 2011 the subgroup of patients that undergo fertility preservation are invited to participate in a prospective study aiming at long-term follow-up after… Read more about this study
- Who is it for?
- Ages Up to 56 years
- Conditions the study is for
- Infertility
- What is being tested?
- fertility preservation, several methods
- Type of treatment
- Surgery or procedure
- How many people
- 50,000 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2009to Dec 2030
- 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 Up to 56 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Cohort collected from the registers of the university hospitals of Sweden, each representing a health care region, from 1995 and ongoing. FP is included in the tax funded healthcare system and data is registered all over the country. Date is also compared with the Swedish tax registry.
Who may be able to join
- infertile patients and patients who undergo fertility preservation
Who cannot join
- Healthy individuals, fertile population
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dan Grandér, Prof contact
Susanne Gruber contact
Sweden1 site, 1 recruiting
- Recruiting
Reproductive Medicine, Karolinska University Hospital
Stockholm, 141 86
Mats Hellström, RN, mats.hellstrom@karolinska.se
Birgit Borgström, MD PhD
About this study
Official title: Studies Aiming at Identifying Predictors for Fertility Treatments' Outcomes and to Evaluate the Efficacy and Safety of Fertility Preservation
This study analyses clinical data prospectively collected for over a decade in several clinical databases. Electronic medical records are available since 1998.
Since 2011 the subgroup of patients that undergo fertility preservation are invited to participate in a prospective study aiming at long-term follow-up after fertility preservation for oncologic and non-oncologic conditions.
Read the detailed description
In this study, the investigators aim at analyze the treatment outcomes of patients with infertility, their clinical characteristics and biochemical parameters aiming at identifying predictors for the treatment outcomes.
For the cohort of patients that have undergone fertility preservation at Karolinska University Hospital, the investigators aim at investigating efficacy and safety of the procedures.
The data can be expanded by using additional databases such as the Regional Cancer Registry and other registries.
Analysis of data collected will allow the investigation of efficacy and safety of fertility preservation, identification of predictors for fertility outcomes,prediction of future activities and costs of the procedures.
- Conditions
- Infertility
- Being tested
- fertility preservation, several methods
- Keywords
- fertility preservation, fertility treatment, safety, efficacy, fertility outcomes, follow-up, cohort
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fertility preservation, several methodsProcedure or surgery
Also called cryopreservation, surgery
fertility preservation using assisted reproductive techniques or not
| Study group | Role | What they receive |
|---|---|---|
| Fertility preservation performed | subgroup analysis by cause of infertility, clinical characteristics, biochemical markers Receives: Procedure: fertility preservation, several methods | |
| Fertility preservation not performed | subgroup analysis by cause of infertility, clinical characteristics, biochemical markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of fertility preservation - Long-term follow-up
Correlation between method of fertility preservation and pregnacy rate
Measured: 2028
Secondary outcomes (4)
Clinical outcome of fertility treatments i breast cancer patients
Fertility treatment vs no fertility treatment i breastcancer patients: effect on survival
Measured: 5-20 years post diagnosis
Clinical outcome of fertility treatments i breast cancer patients
Fertility treatment vs no fertility treatment i breastcancer patients: effect on disease free survival
Measured: 5-7 years post diagnosis
Predictors of effictive fertility treatment
Correlation between clinical variables (age, BMI, oocyte level, administered gonadotropins, infertility) method of fertility preservation and Pregnancy rate
Measured: patient data collected from time of treatment, pregnancy rate until end of study
Efficacy and safety of COS using GnRHa for fertility preservation in BC patients
hCG vs GnRH trigger on effect on number of cryopreserved embryos and oocytes
Measured: Observed outcomes in patients registered between 1995 and 2017. Follow up until end of 2018.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study startSep 2009
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Other
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Kenny Rodriguez-Wallberg, Karolinska Institutet
- Investigators
- Dan Grandér, Prof, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602962
- Sponsor's protocol ID
- KI-KRW-200909-201505
- Status last verified
- May 2023
- First submitted
- 18 May 2015
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wikander I, Lundberg FE, Nilsson H, Borgstrom B, Rodriguez-Wallberg KA. A Prospective Study on Fertility Preservation in Prepubertal and Adolescent Girls Undergoing Hematological Stem Cell Transplantation. Front Oncol. 2021 Jun 30;11:692834. doi: 10.3389/fonc.2021.692834. eCollection 2021.
PubMed 34277437
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies Aiming at Identifying Predictors for Fertility Treatments' Outcomes and to Evaluate the Efficacy and Safety of Fertility Preservation
- ClinicalTrials.gov ID
- NCT04602962
- Acronym / sponsor ID
- KI-KRW-200909-201505
- Conditions
- Infertility
- Keywords
- fertility preservation, fertility treatment, safety, efficacy, fertility outcomes, follow-up, cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- Sep 2009 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Oct 2020 (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.
This study analyses clinical data prospectively collected for over a decade in several clinical databases. Electronic medical records are available since 1998.
Since 2011 the subgroup of patients that undergo fertility preservation are invited to participate in a prospective study aiming at long-term follow-up after fertility preservation for oncologic and non-oncologic conditions.
Detailed description
In this study, the investigators aim at analyze the treatment outcomes of patients with infertility, their clinical characteristics and biochemical parameters aiming at identifying predictors for the treatment outcomes.
For the cohort of patients that have undergone fertility preservation at Karolinska University Hospital, the investigators aim at investigating efficacy and safety of the procedures.
The data can be expanded by using additional databases such as the Regional Cancer Registry and other registries.
Analysis of data collected will allow the investigation of efficacy and safety of fertility preservation, identification of predictors for fertility outcomes,prediction of future activities and costs of the procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fertility preservation performed | – | Procedure: fertility preservation, several methodssubgroup analysis by cause of infertility, clinical characteristics, biochemical markers |
| Fertility preservation not performed | – | –subgroup analysis by cause of infertility, clinical characteristics, biochemical markers |
Who may qualify
- Ages
- Up to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cohort collected from the registers of the university hospitals of Sweden, each representing a health care region, from 1995 and ongoing. FP is included in the tax funded healthcare system and data is registered all over the country. Date is also compared with the Swedish tax registry.
Key inclusion criteria (1 listed)
- infertile patients and patients who undergo fertility preservation
Key exclusion criteria (1 listed)
- Healthy individuals, fertile population
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fertility preservation, several methodsAlso: cryopreservation, surgeryfertility preservation using assisted reproductive techniques or not | Procedure or surgery | Fertility preservation performed |
Primary outcome
Efficacy and safety of fertility preservation - Long-term follow-up
Time frame: 2028
Correlation between method of fertility preservation and pregnacy rate
4 secondary outcomes
Clinical outcome of fertility treatments i breast cancer patients
Time frame: 5-20 years post diagnosis
Clinical outcome of fertility treatments i breast cancer patients
Time frame: 5-7 years post diagnosis
Predictors of effictive fertility treatment
Time frame: patient data collected from time of treatment, pregnancy rate until end of study
Efficacy and safety of COS using GnRHa for fertility preservation in BC patients
Time frame: Observed outcomes in patients registered between 1995 and 2017. Follow up until end of 2018.
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 30 May 2023.
- Derived from this study: PubMed 34277437Wikander I, Lundberg FE, Nilsson H, Borgstrom B, Rodriguez-Wallberg KA. A Prospective Study on Fertility Preservation in Prepubertal and Adolescent Girls Undergoing Hematological Stem Cell Transplantation. Front Oncol. 2021 Jun 30;11:692834. doi: 10.3389/fonc.2021.692834. eCollection 2021.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Dan Grandér, Prof contact
Susanne Gruber contact
Dan Grandér, Prof study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Dan Grandér, Prof (dan.grander@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and safety of fertility preservation - Long-term follow-up (time frame: 2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04602962, which also lists 1 linked publication.
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 30 May 2023.