Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

NCT ID: NCT00610077

Last Updated: 2008-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2006-07-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Letrozole

Group Type: EXPERIMENTAL

Letrozole

Intervention Type: DRUG

Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles

2

Clomiphene citrate

Group Type: ACTIVE_COMPARATOR

Clomiphene citrate

Intervention Type: DRUG

Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles

Interventions

Letrozole

Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles

Intervention Type: DRUG

Clomiphene citrate

Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles

Intervention Type: DRUG

Other Intervention Names

Letroz; Ferotab

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Sun Pharmaceutical Industries Limited

Principal Investigators

Mandakini Parihar, M.D., D.G.O.

Role: PRINCIPAL_INVESTIGATOR

Director, IVF Centre, Chembur

Locations

IVF Centre, Chembur,

Mumbai, Maharashtra, India

Countries

India

Other Identifiers

LET/SPIL/03/06

Identifier Type: -

Identifier Source: org_study_id