Ovarian stimulation using Follitropin delta and Dydrogesterone for oocyte donors
Luteal Phase Ovarian Stimulation With Follitropin Delta and Dydrogesterone: a Randomized Cross Over Pilot Trial
This study is testing two different ways to help women donate eggs using a new medication to see which method works better and is safer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 36 Years |
| Sex | Female |
| Sponsor | CRG UZ Brussel Academic / other |
| Locations | 1 site (Brüssel) |
| Trial ID | NCT05521828 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a new approach to controlled ovarian stimulation (COS) for oocyte donors by comparing luteal phase ovarian stimulation (LPOS) with progestin-primed ovarian stimulation (PPOS). The study will involve 50 participants who will undergo two different treatment sequences, each involving a cycle of ovarian stimulation with Follitropin delta and Dydrogesterone. Participants will be monitored through hormonal assessments and ultrasound evaluations to track follicular growth and response to treatment. The aim is to determine the effectiveness and safety of these stimulation protocols in improving oocyte retrieval outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy women aged 18 to 28 with regular menstrual cycles who are willing to donate their oocytes.
Not a fit: Patients with severe endometriosis, hormonal imbalances, or those with contraindications to gonadotropins may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the efficiency of oocyte donation procedures, leading to better outcomes for patients undergoing fertility treatments.
How similar studies have performed: Previous studies have shown promising results with similar ovarian stimulation protocols, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body mass Index (BMI) ≥18 to \< 28 * Signed informed consent * Regular menstrual cycle length i.e. 24-35 days Exclusion Criteria: * Contraindications to the use of gonadotropins * Endometriosis grade 3-4 * Patients with Anti-mullerian hormone (AMH) \<1.1 ng/ml and/or antral follicular count (AFC)\<7 * Patients with Follicle Number Per Ovary (FNPO) ≥ 19 and/or AMH \>5ng/ml * Patients under contraception with hormonal intrauterine device (IUD) * Any untreated endocrine abnormality
Where this trial is running
Brüssel
- Brussels Ivf — Brüssel, Belgium (Recruiting)
Study contacts
- Study coordinator: Christophe Blockeel, Prof, MD
- Email: Christophe.Blockeel@uzbrussel.be
- Phone: + 32 2 4776699
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.