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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT01116167
Eligibility Criteria:
Inclusion Criteria:
* Chinese women
* Age between 20 and 40 years.
* Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3):
1. Oligo- or anovulation
2. Clinical and/or biochemical signs of hyperandrogenism
3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)
* At least one patent tube and normal uterine cavity shown by hysterosalpingogram, HyCoSi or diagnostic laparoscopy within three years.
* Sperm concentration 20×106/mL and progressive motility (grades a and b) ≥50%.
Exclusion Criteria:
* Use of hormonal drugs or other medications including Chinese herbal prescriptions in the past 3 months.
* Patients with known sever organ dysfunction or mental illness.
* Pregnancy, post-abortion or postpartum within the past 6 weeks.
* Breastfeeding within the last 6 months.
* Not willing to give written consent to the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT01116167
Study Brief:
Protocol Section:
NCT01116167