GnRH agonist versus dual hCG/GnRH trigger for ovulation induction in fertility preservation
Official title: Ovulation Induction With GnRH Analogue or Dual Trigger?
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07546136 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 46 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Status | Recruiting |
| Started | April 7, 2025 |
| Main results expected | March 6, 2027 |
| Study ends | April 3, 2027 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT07546136 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Combining ovarian tissue freezing with egg (oocyte) freezing versus egg freezing alone
This research will test whether combining ovarian tissue freezing with egg freezing helps adult women with cancer preserve more fertility than egg freezing alone.
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This trial tests whether taking a two-month break from combined hormonal birth control versus starting ovarian stimulation immediately affects outcomes for ovary-bearing people aged 18–40 who are planning to freeze their eggs.
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This project tests whether removing lesions by hysteroscopy combined with hormonal therapy helps women with endometrial cancer or atypical hyperplasia preserve fertility and achieve good pregnancy and cancer-control outcomes.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.