Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: Letrozole; Drug: Clomiphene citrate

• Registration Number: NCT00610077
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

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

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

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2008-01
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-02-06
• Last Update Submitted: 2008-02-06
• Study First Posted: 2008-02-07
• Last Update Posted: 2008-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Letrozole	Letrozole
2	Clomiphene citrate	Clomiphene citrate

Primary Outcome Measures

Name	Time	Method
Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).	3 cycles

Secondary Outcome Measures

Name	Time	Method
Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.	3 cycles
Safety	3 cycles

Trial Locations

Locations (1)

IVF Centre, Chembur,; 🇮🇳 Mumbai-, Maharashtra, India