Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Subclinical Hypothyroidism, Female Infertility
About this trial
This is an interventional treatment trial for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries focused on measuring Letrozole, Levothyroxine, PCOS, Subclinical hypothyroidism
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
Sites / Locations
- Al-Hussein University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Letrozole Group
Letrozole plus levothyroxine
Participants randomized to letrozole group will take 5mg tablets orally daily for 5 days starting on day 3 of cycle. Dose can be adjusted up to 7.5mg based on ovulation response, maintained for subsequent cycles. Treatment continues for up to 6 ovulatory cycles or until pregnancy occurs. Ovulation assessed by follicular monitoring and progesterone. Compliance monitored by pill counts and diary. Routine antenatal care if pregnant. Adverse effects monitored per guidelines. Participants followed for multiple pregnancies. Tablets taken at same time each day. Maximum treatment period is 6 months.
Participants randomized to this group will take letrozole tablets at same dose and schedule as letrozole only group. In addition, they will take levothyroxine tablets orally once daily. Levothyroxine dose will start at 25mcg and be titrated based on TSH level, with a target TSH in the normal range. Participants will take levothyroxine at approximately same time each day. Letrozole dosing and schedule as described for other group. Treatment continues for up to 6 ovulatory cycles or until pregnancy occurs. Ovulation assessed by follicular monitoring and progesterone. Compliance monitored by pill counts, TSH levels and diary. Routine antenatal care if pregnant. Adverse effects monitored per guidelines. Participants followed for multiple pregnancies. Maximum treatment period is 6 months.