Status:
COMPLETED
Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility
Lead Sponsor:
Sun Pharmaceutical Industries Limited
Conditions:
Infertility
Eligibility:
FEMALE
20-38 years
Phase:
PHASE3
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, comparat...
Detailed Description
MAIN OUTCOME MEASURE(S): Occurrence of ovulation, endometrial thickness and pregnancy rates.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00610077
Start Date
December 1 2004
End Date
July 1 2006
Last Update
February 7 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IVF Centre, Chembur,
Mumbai, Maharashtra, India, 400071