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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 35
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Ain Shams University Hospitals
RECRUITING
Cairo
Contact Information
Primary
Mohamed Adel Mousa, MSC
sedyyasedy@gmail.com
+201093429998
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2024-09-10
Participants
Target number of participants: 64
Treatments
Active_comparator: Group 1 (Letrozole group)
About 32 patients will receive letrozole 2.5 mg tablets only , once daily from the third date of the menses for 5 days for 3 successive periods
Active_comparator: Group 2 (Letrozole and Clomiphene Citrate)
About 32 patients will receive combined letrozole 2.5 mg tablets once daily and clomiphene citrate 50 mg tablets once daily from the third date of the menses for 5 days for 3 successive periods
Sponsors
Leads: Egymedicalpedia
Collaborators: Ain Shams University

This content was sourced from clinicaltrials.gov

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