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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT00478504
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18 - 39
2. BMI \< 36
3. Infertility due to anovulation
4. PCOS: At least two of the following diagnostic criteria of:
1. Oligo/amenorrhoea
2. Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence
3. USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of \> 10 ml)
5. No recent (within 6 months) treatment for induction of ovulation
6. Normal semen analysis (WHO 1999)
7. Proven patency of at least one Fallopian tube
Exclusion Criteria:
1. Inability to give informed consent
2. Contraindication to letrozole or clomifene citrate
3. Absence of any inclusion criteria
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT00478504
Study Brief:
Protocol Section:
NCT00478504