Single-injection corifollitropin α versus daily FSH for egg donors using medroxyprogesterone acetate
Usefulness of Corifollitropin α as Alternative to Conventional Daily rFSH Protocols in Oocyte Donors Undergoing Pituitary Suppression With Medroxiprogesterona Acetate (MPA)
This trial will test whether a single corifollitropin α injection can replace daily FSH shots for healthy egg donors taking medroxyprogesterone acetate (MPA).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA Academic / other |
| Locations | 2 sites (Valencia, Valencia and 1 other locations) |
| Trial ID | NCT06193135 on ClinicalTrials.gov |
What this trial studies
Healthy women donating oocytes and suppressed with medroxyprogesterone acetate will be treated with either one subcutaneous dose of corifollitropin α or with daily follitropin beta injections for controlled ovarian stimulation. Participants will be monitored with serial ultrasound scans and hormone measurements and will undergo standard oocyte retrieval. Key outcomes include the number of mature oocytes retrieved, incidence of premature luteinization, safety measures, and donor-reported burden and adherence. Screening includes age, BMI, antral follicle count, karyotype, and infectious disease testing to ensure donor suitability.
Who should consider this trial
Good fit: Healthy women aged 18–35 who meet oocyte-donor criteria (BMI 18–28, regular cycles, AFC >12, no PCOS, normal karyotype, and negative infectious disease screening) are ideal candidates.
Not a fit: Women outside the specified age or BMI ranges, with low ovarian reserve, polycystic ovaries, or other exclusionary medical conditions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, donors may need fewer injections and experience less anxiety and burden while achieving similar egg retrieval outcomes.
How similar studies have performed: Previous IVF studies using corifollitropin α have shown comparable ovarian responses to daily rFSH, but its use specifically in oocyte donors under MPA suppression is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signature of the subject's informed consent prior to any trial-related activity. * Age between 18 and 35 years (both inclusive). * Regular menstrual cycle, from 25 to 35 days (both inclusive). * Absence of physical and psychological illness at the time of donation at the discretion of the investigator. * BMI 18-28 kg/m2 (both inclusive) at the time of donation. * No personal or family history of interest at the discretion of the investigator. * Normal uterus and ovaries, without organic pathology. * No polycystic ovaries. * Antral follicle count greater than 12 in the sum of the two ovaries at the time of the screening visit. * Normal karyotype. * Negative infectious disease screening (Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus and Syphilis). * General analysis with hemogram, hemostasis and biochemistry with parameters within normality. Exclusion Criteria: * Concurrent participation in another clinical trial. * Previous participation in this clinical trial. * Use of long-term hormonal contraception (hormonal IUD or subcutaneous implants) at least 1 month prior to enrollment. * Any systemic or metabolic disorder (i.e.: diabetes...) that contraindicates the use of gonadotropins. * Personal history of thrombophlebitis and thromboembolic phenomena and hypertension. * Severe hepatic insufficiency, cardiovascular disease * Suspicion or evidence of breast malignancy or hormone-dependent genital organs. * Known hypersensitivity to AMP or its excipients * Any reason for exclusion from the oocyte donation program.
Where this trial is running
Valencia, Valencia and 1 other locations
- IVI Valencia — Valencia, Valencia, Spain (Recruiting)
- Ivi Valencia — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: JUAN GILES, PhD
- Email: juan.giles@ivirma.com
- Phone: +34 963.05.90.00
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.