Comparing rFSH alone versus rFSH plus rLH during dydrogesterone-based ovarian stimulation for IVF
Comparison of rFSH Alone Versus rFSH+rLH in Dydrogesterone-Based Progestin Protocol Cycles
This project will see if adding recombinant LH to recombinant FSH improves the number of mature eggs and embryo outcomes for women aged 20–43 undergoing IVF with a dydrogesterone-based PPOS protocol.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 43 Years |
| Sex | Female |
| Sponsor | Centrum Clinic IVF Center Academic / other |
| Locations | 2 sites (Ankara, Ankara and 1 other locations) |
| Trial ID | NCT07348757 on ClinicalTrials.gov |
What this trial studies
This prospective observational study will follow women undergoing IVF with a dydrogesterone-based Progestin-Primed Ovarian Stimulation (PPOS) protocol who receive either recombinant FSH alone or a combination of recombinant FSH and recombinant LH as part of routine care. Treatment choice is made by the treating physician and no additional procedures or medications beyond standard IVF care are required. Participants will have regular ultrasound and blood monitoring to track follicle growth and timing of final oocyte maturation, with oocyte retrieval and embryo culture performed per clinic protocol. The primary outcome is the number of mature (MII) oocytes, and secondary outcomes include the number of good-quality blastocysts, implantation rate, and ongoing pregnancy rate.
Who should consider this trial
Good fit: Women aged 20–43 with BMI <30 kg/m², AMH >1 ng/mL, at least one ovary, regular or clinically acceptable cycles, and who are planning IVF/ICSI with a dydrogesterone-based PPOS protocol are the intended candidates.
Not a fit: Patients with very low ovarian reserve (AMH ≤1 ng/mL), prior bilateral oophorectomy, diagnosed adenomyosis or hydrosalpinx, those planning PGT-A, or with other major contraindications to stimulation are unlikely to be eligible or to gain from this comparison.
Why it matters
Potential benefit: If adding recombinant LH proves helpful, patients could obtain more mature eggs and higher-quality embryos without extra procedures.
How similar studies have performed: Previous trials comparing rFSH alone versus rFSH+rLH have shown mixed results with some benefits in selected subgroups, but evidence specifically in dydrogesterone-based PPOS cycles is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 20 to 43 years. * BMI \< 30 kg/m². * AMH \> 1 ng/mL. * Undergoing IVF/ICSI treatment with a dydrogesterone-based PPOS protocol. * Women with regular menstrual cycles or clinically acceptable cycle pattern for stimulation. * Ability to provide informed consent and comply with study procedures. * Presence of at least one ovary and eligibility for controlled ovarian stimulation Exclusion Criteria: * Cycle cancellation due to lack of viable embryos. * Prior or planned PGT-A in the same cycle. * Adenomyosis diagnosed by ultrasound or MRI. * Uncorrected uterine anomalies (e.g., bicornuate, unicornuate, didelphys uterus). * Presence of hydrosalpinx. * Use of oral contraceptives or luteal-phase estradiol within 3 months before stimulation. * Refusal or inability to provide informed consent. * Severe systemic disease or contraindication to ovarian stimulation. * Prior bilateral oophorectomy
Where this trial is running
Ankara, Ankara and 1 other locations
- Centrum Clinic IVF Center — Ankara, Ankara, Turkey (Türkiye) (Recruiting)
- Bahçeci IVF Center — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Emre G pabuçcu, Professor
- Email: emregpabuccu@gmail.com
- Phone: +905324147844
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.