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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07346235
Eligibility Criteria:
Inclusion Criteria:
1. Body Mass Index (BMI) 18-30 kg/m².
2. Predicted normal ovarian reserve:
3. Anti-Müllerian Hormone (AMH) 1.2-3.5 ng/mL (measured within 12 months), AND Antral Follicle Count (AFC) 8-20 (both ovaries combined, measured on day 2-5 of the cycle).
4. First or second IVF/ICSI cycle.
5. Planned GnRH antagonist protocol.
6. Both ovaries present and accessible.
7. Written informed consent provided voluntarily.
Exclusion Criteria:
1. Predicted poor or high ovarian response (AMH \<1.2 or \>3.5 ng/mL; AFC \<8 or \>20).
2. Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria.
3. Severe endometriosis (Stage III-IV per ASRM).
4. Severe uterine abnormalities affecting implantation.
5. Previous complete fertilization failure (fertilization rate \<30%).
6. Severe male factor (sperm count \<5 million/mL, or requirement for donor sperm/TESE).
7. Uncontrolled endocrine disorders (uncontrolled hypothyroidism, hyperprolactinemia, diabetes).
8. Contraindications to pregnancy or gonadotropins.
9. Participation in another clinical trial within 30 days.
10. Inability to provide informed consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT07346235
Study Brief:
Protocol Section:
NCT07346235