NCT07546136 Ovulation Induction With GnRH Analogue or Dual Trigger?
| NCT ID | NCT07546136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Oncological Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2027-03-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 200 participants in total. It began in 2025-04-07 with a primary completion date of 2027-03-06.
⚠ 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
Most medically assisted procreation (ART) techniques, including oocyte cryopreservation for fertility preservation, involve controlled ovarian stimulation. This procedure uses exogenous hormones, primarily follicle-stimulating hormone (FSH), to promote the development of multiple ovarian follicles in a single menstrual cycle. Once follicles reach a suitable number and size, oocyte retrieval (pick-up) is scheduled after pharmacological ovulation induction. Human chorionic gonadotropin (hCG) has been routinely used for ovulation induction, but a common complication is ovarian hyperstimulation syndrome (OHSS). Studies have shown that in antagonist protocols, using a gonadotropin-releasing hormone agonist (GnRH-a) instead of hCG reduces OHSS risk. However, GnRH-a triggers luteal phase dysfunction, likely due to depletion of pituitary LH reserves and lack of LH-like activity (present in hCG), resulting in lower clinical pregnancy rates and occasionally very low oocyte yield. To maximize oocyte retrieval and minimize OHSS risk, a combined "dual trigger" approach using both GnRH-a and hCG has been proposed, leveraging benefits of both agents. Currently, limited data exist regarding the optimal ovulation induction strategy in oncological patients undergoing fertility preservation via oocyte cryopreservation before gonadotoxic therapy, where maximizing outcomes and minimizing complications is critical. This study aims to compare the number of oocytes retrieved per cycle in oncological patients undergoing fertility preservation with ovulation induced by either GnRH-a alone or dual trigger (GnRH-a + hCG). It will also assess the oocyte retrieval rate (number of oocytes retrieved/number of follicles aspirated), number of mature oocytes, and incidence of moderate OHSS within 7 days post-retrieval in both groups. Additionally, it will explore correlations between serum estradiol (E2) and luteinizing hormone (LH) levels on the trigger day and oocyte yield. Approximately 200 patients aged ≥18 years will be consecutively enrolled over 2 years and 2 months. Retrospective period considered: from January 1, 2023, to the study initiation date. Patients will be assigned by clinicians to one of two groups based on clinical characteristics: Group 1: Ovulation induced with 0.2 mg subcutaneous triptorelin (Decapeptyl®) Group 2: Ovulation induced with 0.2 mg subcutaneous triptorelin plus 1000-5000 IU urinary hCG (Gonasi®) Treatment follows standard clinical practice.
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 * AMH \> 1.00 ng/mL * Obtaining written informed consent to participate in the study and for data processing Exclusion Criteria: * Hypersensitivity to one or more of the active substances used during the treatment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07546136 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 NCT07546136 currently recruiting?
Yes, NCT07546136 is actively recruiting participants. Contact the research team at giulia.borghese@aosp.bo.it for enrollment information.
Where is the NCT07546136 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT07546136 clinical trial?
NCT07546136 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 200 participants.