NCT07546123 Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone
| NCT ID | NCT07546123 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Oncological Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 127 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2029-07 |
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 127 participants in total. It began in 2025-08-25 with a primary completion date of 2029-07.
⚠ 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
Fertility preservation is a crucial aspect of care for oncological patients undergoing gonadotoxic treatments such as chemotherapy, radiotherapy, or surgery, which can significantly reduce ovarian reserve and cause infertility or premature menopause. Among available techniques, oocyte cryopreservation is well-established with high survival rates but requires controlled ovarian stimulation and may not be suitable for prepubertal patients or those needing urgent cancer therapy. Ovarian tissue cryopreservation offers advantages by preserving a larger number of primordial follicles, can be performed anytime in the menstrual cycle regardless of age, and also helps restore ovarian endocrine function. Combining ovarian tissue cryopreservation followed by oocyte cryopreservation may maximize fertility preservation by safeguarding more follicles and ensuring availability of mature oocytes. This study will collect data from two patient groups: Group 1: patients undergoing ovarian tissue cryopreservation followed by oocyte cryopreservation (combined treatment) Group 2: patients undergoing oocyte cryopreservation alone. Group assignment is based on planned gonadotoxic therapy and available time before treatment initiation, according to clinical practice. The study aims to compare the number of oocytes retrieved per ovarian stimulation cycle between the two groups, along with the oocyte retrieval rate (number of oocytes retrieved/number of aspirated follicles), number of mature oocytes (metaphase II), incidence of moderate ovarian hyperstimulation syndrome within 7 days post-retrieval, and correlations between serum estradiol and luteinizing hormone levels on trigger day and oocyte yield. Approximately 127 patients aged 18 to 46 will be consecutively enrolled at the UO Gynecology and Human Reproduction Pathophysiology, IRCCS AOUBO Policlinico di Sant'Orsola. This is a cross-sectional, single-center, observational study with both retrospective and prospective enrollment. The retrospective period considered is from January 1, 2022, to the study start date. The study duration is 4 years and 3 months.
Eligibility Criteria
Inclusion Criteria: * Patient with oncological disease eligible for potentially gonadotoxic therapy * BMI ≥ 17.5 kg/m² and ≤ 32 kg/m² * Age ≥ 18 years and ≤ 46 years Exclusion Criteria: * Hypersensitivity to one or more of the active substances used during ovarian stimulation treatment * Positive for HBV, HCV, HIV, or Treponema pallidum * Lack of oncological clearance
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07546123 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 46 Years, studying Oncological Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07546123 currently recruiting?
Yes, NCT07546123 is actively recruiting participants. Contact the research team at die.raimondo@gmail.com for enrollment information.
Where is the NCT07546123 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT07546123 clinical trial?
NCT07546123 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 127 participants.