Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

Study Overview
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Brief Summary
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OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited. Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles) were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S): Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.

Detailed Description
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MAIN OUTCOME MEASURE(S): Occurrence of ovulation, endometrial thickness and pregnancy rates.

Official Title
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An Open, Randomized, Parallel-Group, Multicentric, Comparative Study of Letrozole With Clomiphene Citrate for Induction of Ovulation in Anovulatory Infertility.

Conditions
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Infertility

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females with anovulatory infertility 20-38 years of age. Diagnosis of anovulatory infertility as established by standard criteria. Normal Pelvic USG and bilateral tubal patency Willingness and giving written Informed Consent. Exclusion Criteria: Uterine and adnexal pathology e.g. leiomyomata Ovarian cyst Hyperprolactinaemia Hyperthyroidism or Hypothyroidism* FSH >9mIU/ml (during early follicular phase).* (As per Chemoluminescence method) Previous surgery related to genital tract as per history Appendicitis, peritonitis, genital tuberculosis as per history and/or having an abnormal pelvic anatomy Impaired hepatic /renal function Diabetes mellitus/Random blood sugar- > 140mg/dl Drugs likely to interfere with ovulation Alcohol intake as per history History of hypersensitivity to the study drug or to its excipients Planned travel outside the study area for a substantial portion (>5 days) of the study period by potential participants Lack of willingness to give informed written consent Participation in any clinical study within the preceding 1 month

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 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: 1<br>Letrozole | Drug: Letrozole<br>* Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles<br>* Other names: Letroz;|
| Active Comparator: 2<br>Clomiphene citrate | Drug: Clomiphene citrate<br>* Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles<br>* Other names: Ferotab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG). |  | 3 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography. |  | 3 cycles | 
| Safety |  | 3 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Letrozole, Clomiphene citrate, Anovulatory infertility, Ovulation induction