NCT06835088 Cryopreservation of Ovarian Tissue: Reimplantation Rate and Effects on Ovarian Function
| NCT ID | NCT06835088 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Cryopreservation |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2021-09-12 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2021-09-12 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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%. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: \- Oncological pathology still active or relapse
Contact & Investigator
Renato Seracchioli, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06835088 clinical trial?
This trial is open to female participants only, aged 13 Years or older, up to 55 Years, studying Cryopreservation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06835088 currently recruiting?
Yes, NCT06835088 is actively recruiting participants. Contact the research team at renato.seracchioli@aosp.bo.it for enrollment information.
Where is the NCT06835088 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06835088 clinical trial?
NCT06835088 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Renato Seracchioli, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 400 participants.