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:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT00994812
Eligibility Criteria:
Inclusion Criteria:
1. age \< 40 years at entry
2. BMI \> 19 kg/m2
3. Infertility lasting \> 1 year
4. Criteria for PCOS are as defined by ESHRE/ASRM: at least two of the following findings:
* polycystic ovaries shown by vaginal ultrasonography (more than 12 subcapsular follicles of 3-8 mm diameter in one plane of the ovary)
* oligomenorrhea or amenorrhea
* clinical manifestations of hyperandrogenism such as a hirsutism score of \> 7 according to Ferriman and Gallwey (Ferriman \& Gallwey 1961)and/or an elevated serum testosterone level (\> 2.7 nmol/l).
Exclusion Criteria:
1. diabetic subjects
2. alcohol users
3. active liver disease (ALAT \> +2 SD the upper normal value i.e.\> 100IU/l)
4. hormonal drugs
5. past or present cardiac failure (NYHA I-IV)
6. liver or renal failure (S-Creatinine above the normal value ie.124 umol/l)
7. pregnancy or lactation
8. hypersensitivity to metformin
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00994812
Study Brief:
Protocol Section:
NCT00994812