CryopreservationNCT06835088
Cryopreservation of Ovarian Tissue: Reimplantation Rate and Effects on Ovarian Function
An observational study of Cryopreservation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Premature ovarian failure (POI) is a clinical syndrome defined by the loss of ovarian activity before age 40. POI is characterized by amenorrhea or oligomenorrhea with elevated gonadotropins, low estradiol and serious consequences on fertility. The prevalence of POI in the general population is about 1%. Read more about this study
- Who is it for?
- Ages 13 to 55 years, women only
- Conditions the study is for
- Cryopreservation
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2021to 30 Dec 2031
- 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 13 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women aged between 13 and 55 years old suffering from oncological pathologies that require gonadotoxic treatments and who undergo prior to these treatments a collection of ovarian tissue for cryopreservation and possible subsequent orthotopic or heterotropic reimplantation in order to restore ovarian function and fertility
Who may be able to join
- Age: 13-55 years
- Suffering from diseases that require gonadotropic treatments
- Have been subjected to sampling and cryopreservation of ovarian tissue at the Operative Unit of Gynecology and Pathophysiology of Human Reproduction of the Sant'Orsola Polyclinic in Bologna
- Informed Consent Acquisition
Who cannot join
- Oncological pathology still active or relapse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rossella Vicenti contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Renato Seracchioli, MD, +390512143944, renato.seracchioli@aosp.bo.it
Rossella Vicenti, rossella.vicenti@unibo.it
About this study
Official title: Cryopreservation Of Ovarian Tissue: Assessment Of Reimplantation Rate And Effects On Ovarian Function
Premature ovarian failure (POI) is a clinical syndrome defined by the loss of ovarian activity before age 40. POI is characterized by amenorrhea or oligomenorrhea with elevated gonadotropins, low estradiol and serious consequences on fertility.
The prevalence of POI in the general population is about 1%. In recent years, the incidence of iatrogenic POI in cancer women is increasing: 4% of patients of fertile age are diagnosed with neoplasms and gonadal treatments that can sterilize them, such as chemotherapy and radiotherapy. Preserving fertility is a key objective for many cancer patients.
Before gonadotoxic treatments, patients in the post-pubertal age with future desire for pregnancy may opt for two main methods of preservation of fertility (FP): egg cryopreservation (OC) after ovarian stimulation and cryopreservation of ovarian tissue (OTC). An important limitation of the latter technique is the reduced number of patients who return to use the cryopreserved material, leading to a negative impact on the evaluation of the effectiveness of the procedure. The best way to maximise the effectiveness of the procedure in clinical and economic terms would be to increase the number of patients who continue the cryopreservation path by completing it with subsequent reimplantation. It would also be useful to improve the follow-up of these patients by evaluating their ovarian function over time, before and after the removal and reimplantation, through the study of bone metabolism, cardiovascular risk and psychological function in these women.
Read the detailed description
Premature ovarian failure (POI) is a clinical syndrome defined by the loss of ovarian activity before age 40. POI is characterized by amenorrhea or oligomenorrhea with elevated gonadotropins, low estradiol and serious consequences on fertility. The prevalence of POI in the general population is about 1%. In recent years, the incidence of iatrogenic POI in cancer women is increasing: 4% of patients of fertile age are diagnosed with neoplasms and gonadal treatments that can sterilize them, such as chemotherapy and radiotherapy. Preserving fertility is a key objective for many cancer patients. The American Society of Clinical Oncology (ASCO) says that healthcare professionals who care for cancer patients should address infertility as soon as possible before starting treatment. In addition, the demand for fertility preservation for non-oncology diseases as well as personal reasons has increased significantly, and meeting this demand is a major challenge.
Before gonadotoxic treatments, patients in the post-pubertal age with future desire for pregnancy may opt for two main methods of preservation of fertility (FP): egg cryopreservation (OC) after ovarian stimulation and cryopreservation of ovarian tissue (OTC). The OC has been proven to be a reproducible, safe and effective technique for several years. However, it has some important limitations: OC may delay the start of treatment for cancer; in some specific types of cancer, ovarian stimulation should be avoided; the technique cannot be performed in prepubertal patients.
In these cases, OTC, a technique which has emerged from its experimental phase, now safe and with an increasing number of successes, is considered as the unique option for FP. Also, unlike OC, OTC allows the induction of puberty in prepubertal patients, restoration of ovarian hormonal function for 3-7 years, until the graft is active, and may be renewed by subsequent reimplantation of orthotopic or heterotropic tissue.
An important limitation of this technique is the reduced number of patients who return to use the cryopreserved material, which has a negative impact on the evaluation of the effectiveness of the procedure. Several causes in the period between ovarian sampling and transplantation may justify this low rate, including: i) loss of desire for pregnancy; ii) recurrence of cancer; iii) death of the patient; iv) financial reasons; ) fear of cancer recurrence due to contamination of ovarian sampling; vi) occurrence of spontaneous pregnancies; vii) absence of current partner.
The best way to maximise the effectiveness of the procedure in clinical and economic terms would be to increase the number of patients who continue the cryopreservation path by completing it with subsequent reimplantation. It would also be useful to improve the follow-up of these patients by evaluating their ovarian function over time, before and after the removal and reimplantation, through the study of bone metabolism, cardiovascular risk and psychological function in these women.
- Conditions
- Cryopreservation
- Keywords
- cryopreservation, ovarian tissue, ovarian function
What is being measured
The primary outcome is the main question the study is designed to answer.
Causes and factors that influence the low rate of reimplantation of ovarian tissue
Investigate the causes and factors that influence the low rate of reimplantation of ovarian tissue after the phase of collection and cryopreservation
Measured: At least 5 years after surgery at first follow-up
Early ovarian failure
Effects of early ovarian failure in this category of women, particularly in terms of bone metabolism (through Bone densitometry with a dual-energy x-ray absorptiometry, DEXA, Z-score. BMD:> -2.0 normal; ≤ -2.0:osteoporosi
Measured: At least 5 years after surgery at first follow-up
Early ovarian failure
Effects of early ovarian failure in this category of women, particularly in terms of cardiovascular risk (through ACC/AHA Cardiovascular Risk Calculator, %: <5%: low risk; 5-7.4%: Borderline risk; 7.5-19.9%: intermediate risk; ≥20%: high risk)
Measured: At least 5 years after surgery at first follow-up
Early ovarian failure
Effects of early ovarian failure in this category of women, particularly in terms of psychological function (through Short Form36 HealthSurvey (SF-36), score: 0-100
Measured: At least 5 years after surgery at first follow-up
Early ovarian failure
Effects of early ovarian failure in this category of women, particularly in terms of Middlesex Hospital Questionnaire (MHQ), score: <23: normal; >= 23: abnormal
Measured: At least 5 years after surgery at first follow-up
Early ovarian failure
Effects of early ovarian failure in this category of women, particularly in terms of psychological function through Beck's Depression Inventory, score: 0-63
Measured: At least 5 years after surgery at first follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start12 Sep 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryopreservationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato Seracchioli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835088
- Sponsor's protocol ID
- CRIO-2021
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryopreservation Of Ovarian Tissue: Assessment Of Reimplantation Rate And Effects On Ovarian Function
- ClinicalTrials.gov ID
- NCT06835088
- Acronym / sponsor ID
- CRIO-2021
- Conditions
- Cryopreservation
- Keywords
- cryopreservation, ovarian tissue, ovarian function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 19 Feb 2025 (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.
Premature ovarian failure (POI) is a clinical syndrome defined by the loss of ovarian activity before age 40. POI is characterized by amenorrhea or oligomenorrhea with elevated gonadotropins, low estradiol and serious consequences on fertility.
The prevalence of POI in the general population is about 1%. In recent years, the incidence of iatrogenic POI in cancer women is increasing: 4% of patients of fertile age are diagnosed with neoplasms and gonadal treatments that can sterilize them, such as chemotherapy and radiotherapy. Preserving fertility is a key objective for many cancer patients.
Before gonadotoxic treatments, patients in the post-pubertal age with future desire for pregnancy may opt for two main methods of preservation of fertility (FP): egg cryopreservation (OC) after ovarian stimulation and cryopreservation of ovarian tissue (OTC). An important limitation of the latter technique is the reduced number of patients who return to use the cryopreserved material, leading to a negative impact on the evaluation of the effectiveness of the procedure. The best way to maximise the effectiveness of the procedure in clinical and economic terms would be to increase the number of patients who continue the cryopreservation path by completing it with subsequent reimplantation. It would also be useful to improve the follow-up of these patients by evaluating their ovarian function over time, before and after the removal and reimplantation, through the study of bone metabolism, cardiovascular risk and psychological function in these women.
Detailed description
Premature ovarian failure (POI) is a clinical syndrome defined by the loss of ovarian activity before age 40. POI is characterized by amenorrhea or oligomenorrhea with elevated gonadotropins, low estradiol and serious consequences on fertility. The prevalence of POI in the general population is about 1%. In recent years, the incidence of iatrogenic POI in cancer women is increasing: 4% of patients of fertile age are diagnosed with neoplasms and gonadal treatments that can sterilize them, such as chemotherapy and radiotherapy. Preserving fertility is a key objective for many cancer patients. The American Society of Clinical Oncology (ASCO) says that healthcare professionals who care for cancer patients should address infertility as soon as possible before starting treatment. In addition, the demand for fertility preservation for non-oncology diseases as well as personal reasons has increased significantly, and meeting this demand is a major challenge.
Before gonadotoxic treatments, patients in the post-pubertal age with future desire for pregnancy may opt for two main methods of preservation of fertility (FP): egg cryopreservation (OC) after ovarian stimulation and cryopreservation of ovarian tissue (OTC). The OC has been proven to be a reproducible, safe and effective technique for several years. However, it has some important limitations: OC may delay the start of treatment for cancer; in some specific types of cancer, ovarian stimulation should be avoided; the technique cannot be performed in prepubertal patients.
In these cases, OTC, a technique which has emerged from its experimental phase, now safe and with an increasing number of successes, is considered as the unique option for FP. Also, unlike OC, OTC allows the induction of puberty in prepubertal patients, restoration of ovarian hormonal function for 3-7 years, until the graft is active, and may be renewed by subsequent reimplantation of orthotopic or heterotropic tissue.
An important limitation of this technique is the reduced number of patients who return to use the cryopreserved material, which has a negative impact on the evaluation of the effectiveness of the procedure. Several causes in the period between ovarian sampling and transplantation may justify this low rate, including: i) loss of desire for pregnancy; ii) recurrence of cancer; iii) death of the patient; iv) financial reasons; ) fear of cancer recurrence due to contamination of ovarian sampling; vi) occurrence of spontaneous pregnancies; vii) absence of current partner.
The best way to maximise the effectiveness of the procedure in clinical and economic terms would be to increase the number of patients who continue the cryopreservation path by completing it with subsequent reimplantation. It would also be useful to improve the follow-up of these patients by evaluating their ovarian function over time, before and after the removal and reimplantation, through the study of bone metabolism, cardiovascular risk and psychological function in these women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women aged between 13 and 55 years old suffering from oncological pathologies that require gonadotoxic treatments and who undergo prior to these treatments a collection of ovarian tissue for cryopreservation and possible subsequent orthotopic or heterotropic reimplantation in order to restore ovarian function and fertility
Key inclusion criteria (4 listed)
- Age: 13-55 years
- Suffering from diseases that require gonadotropic treatments
- Have been subjected to sampling and cryopreservation of ovarian tissue at the Operative Unit of Gynecology and Pathophysiology of Human Reproduction of the Sant'Orsola Polyclinic in Bologna
- Informed Consent Acquisition
Key exclusion criteria (1 listed)
- Oncological pathology still active or relapse
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
Causes and factors that influence the low rate of reimplantation of ovarian tissue
Time frame: At least 5 years after surgery at first follow-up
Investigate the causes and factors that influence the low rate of reimplantation of ovarian tissue after the phase of collection and cryopreservation
Early ovarian failure
Time frame: At least 5 years after surgery at first follow-up
Effects of early ovarian failure in this category of women, particularly in terms of bone metabolism (through Bone densitometry with a dual-energy x-ray absorptiometry, DEXA, Z-score. BMD:> -2.0 normal; ≤ -2.0:osteoporosi
Early ovarian failure
Time frame: At least 5 years after surgery at first follow-up
Effects of early ovarian failure in this category of women, particularly in terms of cardiovascular risk (through ACC/AHA Cardiovascular Risk Calculator, %: <5%: low risk; 5-7.4%: Borderline risk; 7.5-19.9%: intermediate risk; ≥20%: high risk)
Early ovarian failure
Time frame: At least 5 years after surgery at first follow-up
Effects of early ovarian failure in this category of women, particularly in terms of psychological function (through Short Form36 HealthSurvey (SF-36), score: 0-100
Early ovarian failure
Time frame: At least 5 years after surgery at first follow-up
Effects of early ovarian failure in this category of women, particularly in terms of Middlesex Hospital Questionnaire (MHQ), score: <23: normal; >= 23: abnormal
Early ovarian failure
Time frame: At least 5 years after surgery at first follow-up
Effects of early ovarian failure in this category of women, particularly in terms of psychological function through Beck's Depression Inventory, score: 0-63
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 19 Feb 2025.
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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.
Rossella Vicenti contact
Renato Seracchioli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Cryopreservation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 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 19 Feb 2025. 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 Italy. 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 Renato Seracchioli, MD (+390512143944, renato.seracchioli@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Causes and factors that influence the low rate of reimplantation of ovarian tissue (time frame: At least 5 years after surgery at first follow-up). The study lists 6 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 19 Feb 2025.