Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism

Launched by MUHAMED AHMED ABDELMOATY MUHAMED ALHAGRASY · Sep 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the best way to help women with both Polycystic Ovary Syndrome (PCOS) and subclinical hypothyroidism become pregnant. The researchers want to find out if a combination of two medications, letrozole and levothyroxine, is more effective for ovulation and achieving pregnancy than using letrozole alone. Participants in the trial will be divided into two groups: one will receive letrozole only, while the other will receive letrozole along with a daily dose of levothyroxine.

To be eligible for this study, women should be between the ages of 20 and 40, have a body mass index (BMI) between 18 and 35, and have been diagnosed with PCOS and subclinical hypothyroidism. They should also have been trying to conceive for at least a year and have normal reproductive organs. Participants can expect to take the medications for up to six months or until they become pregnant, and they will be closely monitored throughout the trial. This study is currently recruiting participants, so it's an important opportunity for those looking for assistance with fertility issues.

Gender

FEMALE

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