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Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

Information source: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Letrozole (Drug); Clomiphene citrate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sun Pharmaceutical Industries Limited

Official(s) and/or principal investigator(s):
Mandakini Parihar, M.D., D.G.O., Principal Investigator, Affiliation: Director, IVF Centre, Chembur

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).

Secondary outcome:

Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.

Safety

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

Eligibility

Minimum age: 20 Years. Maximum age: 38 Years. Gender(s): Female.

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

Locations and Contacts

IVF Centre, Chembur,, Mumbai-, Maharashtra 400071, India
Additional Information

Starting date: December 2004
Last updated: February 6, 2008

Page last updated: August 23, 2015

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