Comparision of letrozole and clomiphen citrate versus letrozole alone in infertility women

Not yet recruiting

• Conditions: Polycystic ovarian syndrome,

• Registration Number: CTRI/2020/06/025536
• Lead Sponsor: All India Institute of Medical Sciences BHUBANESWAR INTRAMURAL GRANT

Brief Summary

In reproductive age group, polycystic ovarian syndrome (PCOS) is most common cause of anovlatory subfertility. Therefore the treatment of subfertility in these women is targeted on ovulation induction.Till date various regimen have been tried to improve ovulation rate, pregnancy rate and live birth. Clomiphene citrate is commonly used for induction in women with PCOS. Letrozole is another drug commonly used as ovulation induction agent in women with poly cystic ovarian syndrome.Because letrozole and clomiphene have different mechanism of action we hypothesized that the combination of these two drugsmay result in an increased pregnancy rate over letrozole alone in women with PCOS.

Objectives: Estimation of pregnancy rate between two groups and estimation of ovulation rate

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-06
• Last Update Posted: 2020-05-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 154

Inclusion Criteria

• Women from age of 18-40 years diagnosed with subfertility with PCOS and no other detectable cause of infertility.
• Proven patency of at least one fallopian tube.
• Sperm count of 15 million/ml and more than 40% motility will be included.

Exclusion Criteria

• Women having other cause of subfertility.
• Recent use of hormonal contraception.
• Hyperprolactinemia, untreated thyroid disease, uncontrolled diabetes.
• Drug allergy or contraindication to letrozole or clomiphene citrate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Conception: a positive serum or urinary test of hCG	1-3 months

Secondary Outcome Measures

Name	Time	Method
Number and size of developing follicle on day 12-14, endometrial thickness on day 12-14, clinical pregnancy: an intrauterine gestational sac, complication related to study medication	1-3 months

Trial Locations

Locations (1)

AIIMS Bhubaneswar, Obstetrics and Gynecology Department; 🇮🇳 Khordha, ORISSA, India

AIIMS Bhubaneswar, Obstetrics and Gynecology Department

🇮🇳Khordha, ORISSA, India

Dr Pruthwiraj Sethi

Principal investigator

9438884132

drpruthwiraj@gmail.com