Combination Letrozole and Clomiphene Citrate Versus Letrozole Alone

Launched by EGYMEDICALPEDIA · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of combining two medications, letrozole and clomiphene citrate, to help women with polycystic ovary syndrome (PCOS) who are having trouble getting pregnant. Letrozole is usually used to treat breast cancer, but it can also help stimulate ovulation in women. Clomiphene citrate, on the other hand, is a well-known treatment that helps women ovulate. The goal of the trial is to see if using both medications together is more effective than using letrozole alone for women with infertility caused by PCOS.

To participate in this trial, women need to be diagnosed with infertility, which means they have not been able to conceive after a certain period of trying, depending on their age. They must also meet specific criteria for PCOS, such as having irregular menstrual cycles or signs of high male hormones. Additionally, participants need to have normal tests related to their reproductive health. Women with other medical conditions that could affect their ability to become pregnant or who are allergic to these medications will not be eligible. Participants can expect to receive close monitoring and support throughout the study as researchers work to find the best treatment options for those facing challenges with fertility.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of infertility, defined as the inability of couple to achieve a pregnancy after 12 months of regular timed unprotected intercourse in women \<35 years of age or after 6 months in women \>35 years of age.
• • Diagnosis of PCOS based on the Rotterdam criteria, including two of the following three findings: oligomenorrhea or chronic anovulation, hyperandrogenism (clinical or laboratory), and polycystic ovary(ies) on ultrasound .
• • Normal HSG
• • Normal semen analysis.
• • Has capacity to participate in the study.
• Exclusion Criteria:
• • Unexplained infertility.
• • Other conditions that can cause chronic anovulation and androgen excess such as hyperthyroidism by thyroid profile.
• • congenital adrenal hyperplasia
• • Cushing
• • Untreated hyperprolactinemia.
• • Medical conditions not well controlled or contraindicated to get pregnant with it like (uncontrolled diabetes mellitus, hypertension) .
• • endometrial hyperplasia/cancer
• • Allergy or contraindications to letrozole or CC. (by history)