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OpenTrials
Completed

NCT Number: NCT00610077

Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

IVF Centre, Chembur,

Mumbai, Maharashtra, 400071, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

letrozole

Drug

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

Other names: Letroz

Clomiphene Citrate

Drug

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

Other names: Ferotab

Primary outcomes

  1. Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).

    Time frame: 3 cycles

Secondary outcomes

  1. Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.

    Time frame: 3 cycles

  2. Safety

    Time frame: 3 cycles

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Feb 7, 2008
Registry last updated
Feb 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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