Clinical trial NCT00610077: Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility
Official title: An Open, Randomized, Parallel-Group, Multicentric, Comparative Study of Letrozole With Clomiphene Citrate for Induction of Ovulation in Anovulatory Infertility.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: Letrozole
Clomiphene citrate
Anovulatory infertility
Ovulation induction
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2008-02-07
Enrollment: 55
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

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

Eligibility 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

Primary outcomes:
measure: Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).
timeFrame: 3 cycles
Secondary outcomes:
measure: Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.
timeFrame: 3 cycles
measure: Safety
timeFrame: 3 cycles
Other outcomes:
Locations:
city: Mumbai-
country: India
facility: IVF Centre, Chembur,
state: Maharashtra
Study officials:
affiliation: Director, IVF Centre, Chembur
name: Mandakini Parihar, M.D., D.G.O.
role: PRINCIPAL_INVESTIGATOR
References: