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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT04175002
Eligibility Criteria:
The inclusion criteria for the study group are:
1. All patients between the aged of 18 to 40 years.
2. Women diagnosed with polycystic ovarian syndrome fulfilling two out of three Rotterdam criteria (ie, oligo- or anovulation, hyperandrogenism, and polycystic ovaries on ultrasound).
3. Healthy volunteer with confirmed fertility (having at least one child previously), with a normal level of basic reproductive hormones and regular interval of the menstrual cycle (26 to 32 days). (Control group)
The exclusion criteria are:
1. Smoking
2. any hormonal treatment or other drugs to treat anovulation for at least 3 months before the study
3. Pregnancy or lactation during the preceding 12 months
4. Systemic disease such as endocrine or eating disorders besides PCOS
5. Diagnosed with a uterine or ovarian disease.
6. Any regular medication such as hormones, herbal substance, statins or corticoids for at least 3 months before the study.
7. History of intrauterine device placement.
The inclusion criteria for the control group are:
1. All patients between the aged of 18 to 40 years.
2. Healthy volunteer with confirmed fertility (having at least one child previously), with a normal level of basic reproductive hormones and regular interval of the menstrual cycle (26 to 32 days).
The exclusion criteria are:
1. Smoking
2. any hormonal treatment or other drugs to treat anovulation for at least 3 months before the study
3. Pregnancy or lactation during the preceding 12 months
4. Systemic disease such as endocrine or eating disorders besides PCOS
5. Diagnosed with a uterine or ovarian disease.
6. Any regular medication such as hormones, herbal substance, statins or corticoids for at least 3 months before the study.
7. History of intrauterine device placement.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04175002
Study Brief:
Protocol Section:
NCT04175002