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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT03086005
Eligibility Criteria:
Inclusion Criteria:
* PCOS diagnostic criteria
* 2003 American Society for Reproductive Medicine(ARSM)/European Society of Human Reproduction and Embryology(ESHRE) consensus meeting guideline
* include two out of three
1. Oligo - or anovulation
2. Clinical or/and biochemical hyperandrogenism
3. Polycystic ovaries on ultrasound, exclusion of other etiologies( ≥ 12 follicles(2-9 mm diameter) in each ovary or ovarian volume(0.5 x length x width x thickness) ≥ 10cm3)
* Anatomical normal uterus
* Normal level of thyroid hormone
Exclusion Criteria:
* Severe endometriosis(stageIII, IV)
* Endometrial thickness less than 7mm in late follicular phase
* Severe male infertility factor, non-obstructive azoospermia
* History of ectopic pregnancy or abortion over the last 3 months
* Unexplained abnormal uterine bleeding
* Congenital adrenal hyperplasia
* Androgen secreting tumor
* Cushing syndrome
* Concurrent administration of metformin, ovulation induction drugs, oral contraceptives within previous 3 months
* Chronic disease(liver, kidney, severe heart failure, DM)
* Any pathology of genital tract
* History of alcohol abuse
* Refuse of study participate consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT03086005
Study Brief:
Protocol Section:
NCT03086005