Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT06193135
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT06193135
Study Brief:
Protocol Section:
NCT06193135