Letrozole Versus Clomifene Citrate for Ovulation Induction

Study Overview
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Brief Summary
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The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.

Official Title
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Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome

Conditions
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Infertility, Polycystic Ovarian Syndrome

Intervention / Treatment
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* Drug: Letrozole
* Drug: Clomifene citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 - 39 BMI < 36 Infertility due to anovulation PCOS: At least two of the following diagnostic criteria of: Oligo/amenorrhoea Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of > 10 ml) No recent (within 6 months) treatment for induction of ovulation Normal semen analysis (WHO 1999) Proven patency of at least one Fallopian tube Exclusion Criteria: Inability to give informed consent Contraindication to letrozole or clomifene citrate Absence of any inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clomiphene citrate<br>Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg | Drug: Clomifene citrate<br>* Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg<br>|
| Active Comparator: Letrozole<br>Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg | Drug: Letrozole<br>* Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | 14 moths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Ovulation rate 2. Number of growing and mature follicles during treatment 3. Miscarriage rate 4. Live-birth rate 5. Multiple pregnancy rate 6. Endometrial thickness |  | 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anovulation, ovulation induction,, polycystic ovarian syndrome, clomifene citrate, letrozole