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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT05410834
Eligibility Criteria:
Inclusion Criteria:
* Capable and willing to provide informed consent
* Females aged 30 and above
* Must meet criteria for one of the following two groups:
1. Documented diagnosis of PCOS OR
2. Normal and regular menstrual cycles with no known diagnosis of PCOS
Exclusion Criteria:
* Menopause, as defined by 12 months of amenorrhea
* Known causes of irregular menstrual bleeding caused by conditions other than PCOS
* Known secondary causes of ovulatory dysfunction and/or hyperandrogenism
* Current pregnancy, active lactation, or less than 6 months postpartum
* Ongoing treatment with ovulation-inducing medication
* History of hysterectomy and/or bilateral oophorectomy
* Severe congestive heart failure (as defined by New York Heart Association - class IV)
* Any life-threatening disease expected to result in death within the next 2 years
* Any malignancy not considered cured. A subject is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening.
* Known severe liver disease
* Known acquired immunodeficiency syndrome such as HIV
* Current treatment with systemic or oral corticosteroid therapy or other immunosuppressive agents
* Known autoimmune disorder (exception: type 1 diabetes)
* Active infectious disease requiring antibiotic or anti-viral agents
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Study:
NCT05410834
Study Brief:
Protocol Section:
NCT05410834