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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT06041204
Eligibility Criteria:
Inclusion Criteria:
Age between 20-40 years
BMI between 18-35 kg/m2
Meet diagnostic criteria for PCOS based on the Rotterdam consensus criteria and ESHRE/ASRM modifications (2018):
Oligo- and/or anovulation Clinical and/or biochemical signs of hyperandrogenism Polycystic ovaries on ultrasound
Subclinical hypothyroidism defined as TSH level between 5-10 mIU/L with normal free T4
Infertility duration ≥ 1 year
Intact ovaries and uterus, confirmed by physical exam and imaging
Normal semen analysis in male partner
No tubal or peritoneal factor contributing to infertility
Effective contraception if not attempting conception
Willing and able to provide informed consent
Exclusion Criteria:
Known thyroid disease or on thyroid medications
Abnormal thyroid function tests other than subclinical hypothyroidism
Hyperprolactinemia
Presence of other causes of infertility such as:
Moderate to severe male factor infertility Bilateral tubal occlusion or peritoneal factors Stage III-IV endometriosis Ovarian failure or insufficiency (high FSH or low AMH)
Previous diagnosis of any type of congenital adrenal hyperplasia
Uncontrolled diabetes (HbA1C \>8%)
History of deep vein thrombosis or thromboembolic events
Any contraindication to letrozole or levothyroxine
Previous use of letrozole or levothyroxine in past 6 months
Current or suspected pregnancy
Breastfeeding
Inability to comply with treatment and follow-up procedures
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT06041204
Study Brief:
Protocol Section:
NCT06041204