Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.

Detailed Description
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Withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation. In the letrozole group, 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days, whereas all patients in the combined metformin-CC group) received metformin HCl [Cidophage®; Chemical Industries Development(CID), Cairo, Egypt], 500 mg three times daily for 6-8 weeks. Then after the end of this period, they received 150 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of menstruation. Patients continued treatment for three successive cycles using the same protocol. Metformin was stopped only when pregnancy was documented.

Official Title
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Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland)
* Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt)
* Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CC resistant PCOS Exclusion Criteria: Congenital adrenal hyperplasia Cushing syndrome Androgen secreting tumors

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letrozole<br> | Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland)<br>* 2.5 mg letrozole daily from day 3 of the menses for 5 days<br>|
| Active Comparator: Metformin-CC<br> | Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt)<br>* metformin HCl 1500 daily for 6-8 weeks<br>Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)<br>* 150 mg CC for 5 days starting from day 3 of menstruation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Principally the ovulation rate as well as the number of growing and mature follicles, serum E2 (pg/ml), serum P (ng/mL), and endometrial thickness (mm). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of pregnancy and miscarriage. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic ovary syndrome, clomiphene resistance, letrozole