Overview

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