RecruitingNot ApplicableNCT06507332

Combination Letrozole and Clomiphene Citrate Versus Letrozole Alone

Combination Letrozole and Clomiphene Citrate Versus Letrozole Alone for Ovulation Induction in Women With Polycystic Ovary Syndrome: A Randomized Control Trial

Sponsor

Egymedicalpedia

Enrollment

64 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Polycystic Ovary Syndrome

Summary

Clomiphene citrate is a non-steroidal triphenylethylene derivative distantly related to diethylstilbestrol. It acts as a selective estrogen receptor modulator (SERM), similar to tamoxifen and raloxifene. All three drugs are competitive inhibitors of estrogen binding to estrogen receptors (ERs) and have mixed agonist and antagonist activity, depending upon the target tissue. Letrozole is a potent, nonsteroidal, aromatase inhibitor, originally used for postmenopausal breast cancer therapy.

Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 35 Years

Inclusion Criteria5

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 Criteria8

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)

Interventions

DRUGLetrozole 2.5mg

to assess and compare the efficacy of Combination of letrozole and clomiphene citrate versus letrozole alone for ovulation induction in women with polycystic ovary syndrome (PCOS)