GnRH agonist versus dual hCG/GnRH trigger for ovulation induction in fertility preservation
Ovulation Induction With GnRH Analogue or Dual Trigger?
We will test whether using a GnRH agonist alone or a dual trigger (GnRH agonist plus hCG) gives better egg retrieval numbers and safety for people with cancer doing egg freezing before gonadotoxic treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 46 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT07546136 on ClinicalTrials.gov |
What this trial studies
This observational study compares two ovulation trigger approaches—GnRH agonist alone versus a dual trigger combining GnRH agonist and hCG—in patients undergoing controlled ovarian stimulation for oocyte cryopreservation prior to cancer treatment. Participants receive antagonist protocols with exogenous FSH and clinicians record the chosen trigger method and clinical outcomes. Key outcomes include number of oocytes retrieved, occurrence of ovarian hyperstimulation syndrome (OHSS), and early luteal function indicators. Data are collected at a single tertiary center and analyzed to see associations between trigger method and yield/safety in the fertility preservation setting.
Who should consider this trial
Good fit: Adults aged 18–46 with an oncological disease planning potentially gonadotoxic therapy, AMH > 1.00 ng/mL, BMI 17.5–32 kg/m², and who can give written informed consent are ideal candidates.
Not a fit: Patients with known hypersensitivity to the drugs used during stimulation, those with AMH ≤ 1.00 ng/mL, or those outside the specified age or BMI ranges are unlikely to benefit from the approaches studied.
Why it matters
Potential benefit: If successful, the results could identify a trigger approach that reduces OHSS risk while preserving or improving oocyte yield for patients preserving fertility before cancer treatment.
How similar studies have performed: Previous work has shown that GnRH-a triggers lower OHSS risk but can impair luteal function and sometimes reduce oocyte yield, while dual-trigger approaches have been used to try to combine benefits with mixed results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Giulia Borghese, MD
- Email: giulia.borghese@aosp.bo.it
- Phone: +393289477743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.