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
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