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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00610077

Enrollment

Registered

2008-02-07

Start date

2004-12-31

Completion date

2006-07-31

Last updated

2008-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Letrozole, Clomiphene citrate, Anovulatory infertility, Ovulation induction

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.

Interventions

DRUGLetrozole

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

DRUGClomiphene citrate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 38 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).	3 cycles

Secondary

Measure	Time frame
Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.	3 cycles
Safety	3 cycles

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026