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 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07359703
Eligibility Criteria:
Inclusion Criteria:
1. Patients undergoing ICSI treatment, with maximum 40 years of age at time of signing the ICF
2. Patients stimulated with GnRH antagonist/HP-hMG or GnRH antagonist/recFSH, scheduled for fresh SET Day 5 with hCG or dual trigger (hCG + GnRH agonist) or Patients stimulated with GnRH antagonist/HP-hMG or GnRH antagonist/recFSH, scheduled for delayed transfer of frozen/thawed SET Day 5 after a GnRH agonist trigger, hCG or dual trigger (hCG + GnRH agonist).
3. Patients undergoing a first, second, third or fourth ICSI cycle
4. Women with body mass index (BMI) higher than 17 and lower than 35
5. Women with regular cycles (between 24 and 35 days)
6. Non-and mild-smokers (\<10 cigarettes/day)
7. AMH 1,1 ng/ml (Bologna criteria), excluding poor responders according to Bologna criteria
8. Patients with fresh ejaculated semen or frozen donor semen
Exclusion Criteria:
1. Patients with less than 8 follicles (≥12mm) on the day of their last echo visit before OPU.
2. Women with history of poor oocyte maturation in a previous cycle (\< 50% MII)
3. Women with Severe Endometriosis (≥ III AFS classification) (in the ovaries and if not surgically treated)
4. Patients scheduled for PGD (preimplantation genetic diagnosis of monogenic/single gene defects) and PGT-A (preimplantation genetic testing on aneuploidy)
5. Couples where the partner has an extremely low sperm count e.g.: severe oligo-astheno-teratozoospermia (OAT) with sperm count below 100.000/ml or TESE.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT07359703
Study Brief:
Protocol Section:
NCT07359703