Dydrogesterone versus GnRH antagonist for women with low ovarian response using double ovarian stimulation
Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation: A Randomized Controlled Non-inferiority Trial
This trial will test whether dydrogesterone or a GnRH antagonist better prevents a premature LH surge and improves outcomes and costs for women with poor ovarian response undergoing double ovarian stimulation for IVF.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 35 Years to 44 Years |
| Sex | Female |
| Sponsor | Bedaya Hospital Academic / other |
| Locations | 2 sites (Cairo, Cairo Governorate and 1 other locations) |
| Trial ID | NCT06212102 on ClinicalTrials.gov |
What this trial studies
This phase II randomized trial assigns women in POSEIDON group 4 to either progestin-primed ovarian stimulation with dydrogesterone or a standard GnRH antagonist protocol during double ovarian stimulation. The primary focus is prevention of premature LH surge, with secondary outcomes including ovarian response, embryo yield, and cost-effectiveness. Key exclusions are PCOS, endometriosis, and a history of recurrent abortion. The trial is conducted at Cairo University and Bedaya Hospital in the Cairo/Giza region.
Who should consider this trial
Good fit: Women with infertility classified as POSEIDON group 4 who are planning double ovarian stimulation as part of IVF and who do not have PCOS, endometriosis, or a history of recurrent miscarriage.
Not a fit: Women with PCOS, endometriosis, recurrent abortion, or those not classified as POSEIDON group 4 or not undergoing double stimulation are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, this could provide a simpler and potentially lower-cost method to prevent premature LH surge and increase usable embryos for women who respond poorly to stimulation.
How similar studies have performed: Progestin-primed ovarian stimulation and GnRH antagonist protocols have each been used successfully in other IVF settings, but randomized head-to-head data specifically in POSEIDON group 4 patients undergoing double stimulation are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients belonging to Poseidon group 4 Exclusion Criteria: * PCOS * Endometriosis * History of recurrent abortion
Where this trial is running
Cairo, Cairo Governorate and 1 other locations
- Cairo University — Cairo, Cairo Governorate, Egypt (Recruiting)
- Bedaya Hospital — Giza, Egypt (Not_yet_recruiting)
Study contacts
- Principal investigator: Samar A Alhofy, M.D, Msc — Cairo University
- Study coordinator: Usama M Fouda, Prof.
- Email: umfrfouda@yahoo.com
- Phone: +201095401375
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.