Trial | NCT00610077  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    55
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.
MAIN OUTCOME MEASURE(S): Occurrence of ovulation, endometrial thickness and pregnancy rates.
Study Started
Dec 31
2004
Primary Completion
Jul 31
2006
Study Completion
Jul 31
2006
Last Update
Feb 07
2008
Estimate

Drug Letrozole

Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles

  • Other names: Letroz

Drug Clomiphene citrate

Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles

  • Other names: Ferotab

1 Experimental

Letrozole

2 Active Comparator

Clomiphene citrate

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
No Results Posted