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Study to compare the effect 2 medicines (Letrozole and Clomiphene Citrate) in patients Of Infertility

â??TO STUDY THE EFFECT OF LETROZOLE VS CLOMIPHENE CITRATE FOR OVULATION INDUCTION IN PATIENTS OF INFERTILITY WITH POLYCYSTIC OVARIAN SYNDROME: A RANDOMIZED CONTROL TRIALâ??

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022908
Enrollment
80
Registered
2020-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Clomiphene Citrate 50mg/day for 5 days. If no ovulation, then step wise increase of the dose to 100mg/150mg : In patients of infertility with PCOS above drug will be given for ovulation

Sponsors

Department of Obstetrics and Gynecology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.PCOS with at least 2 of Diagnostic criteria ï?? Oligomenorrhea / Amenorrhea ï?? Clinical evidence of Acne / hirsutism / alopecia ï?? USG evidence of PCOS 2. Period of Infertility- 1year or more 3. Normal semen analysis as per WHO 2010 criteria 4. Normal pelvic USG 5. At least one patent fallopian tube and a normal uterine cavity as determined by hysterosalpingography or hystero-laproscopy 6. No recent treatment for OI (within 6 months) 7. Willingness and giving written informed consent

Exclusion criteria

Exclusion criteria: 1. Women with uterine /adnexal pathology 2. Women with hyperthyroidism, hypothyroidism or diabetes mellitus 3. BMI >35kg/m2 4. Impaired hepatic / renal function 5. Women with RBS > 140 mg/dl 6. Age > 40 years and obese patients 7. Lack of willingness. 8. Male factor infertility as per WHO 2010 criteria

Design outcomes

Primary

MeasureTime frame
ovulation induction rateTimepoint: 18monts

Secondary

MeasureTime frame
Conception rateTimepoint: 18 months;Endometrial thicknessTimepoint: 18 months;Number of mature follicles per cycleTimepoint: 18 months

Countries

India

Contacts

Public ContactSantosh S Basarakod

Armed Forces Medical College

mkb.doc@gmail.com8806008563

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026