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.
Lead SponsorSun Pharmaceuticals
StatusCompleted No Results Posted
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.
Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles
Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles
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