Single-injection corifollitropin α versus daily FSH for egg donors using medroxyprogesterone acetate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.