Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharmaceutical Industries Limited
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Letrozole; Zuclomiphene

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