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:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-24 @ 1:10 PM
NCT ID:
NCT05021861
Eligibility Criteria:
Inclusion Criteria:
* Females of age group (15-40yrs) diagnosed with PCOS. The diagnosis of PCOS will be according to Rotterdam criteria, when any two out of the following three abnormalities will be present:
1. clinical (hirsutism, acne or acanthosis nigricans) and/or biochemical (raised testosterone) hyperandrogenism ;
2. chronic anovulation (oligomenorrhoea or amenorrhea); and
3. polycystic ovaries on ultrasound (one or both ovaries demonstrate 12 or more follicles measuring 2 to 9 mm in diameter or the ovarian volume exceeds 10 cubic cm on pelvic ultrasound) from department of Obstetrics and Gynaecology, Post Graduate Institute of Medical Sciences, Rohtak.
* presence of ≥20 natural teeth
* BMI (18.5 - 24.9)
* Systemically healthy females {Age and BMI matched with PCOS women} diagnosed on the basis of
1. Regular mensturation,
2. No clinical or biochemical sign of hyperandrogenism and
3. Ultrasound exclusion of PCOS
Exclusion Criteria:
* Previous history of androgen-secreting tumors, congenital adrenal hyperplasia , hyperprolactinemia, or any thyroid dysfunction
* Patients with chronic inflammatory disease such as nephrotic syndrome, chronic renal failure, significant cardiovascular disease, established type 1 or type 2 diabetes mellitus, or active cancer within the past 5 years
* Smokers and alcoholics,
* History of systemic antibiotics or oral contraceptives usage within last 3 months,
* Periapical pathology or other oral inflammatory conditions and any periodontal treatment within 6 months prior to study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
40 Years
Study:
NCT05021861
Study Brief:
Protocol Section:
NCT05021861