To determine the effectiveness of Letrozole versus clomiphene citrate as first line medicine for egg development in women finding difficult to become pregnanat with PCOS (women with improper egg development).
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Sub fertile women with Poly cystic Ovarian Syndrome
- Registration Number
- CTRI/2018/07/014704
- Lead Sponsor
- Batiston Decruse Waanbah
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 148
Inclusion Criteria
All sub fertile women with PCOS (Diagnosis by Rotterdam criteria).
Exclusion Criteria
1. Previously treated with Clomiphene citrate/Letrozole.
2. Chronic kidney disease/ liver disease or any other chronic illnesses.
3. Patients with severe male factor and bilateral tubal blockage.
4. Patients on insulin sensitizers and any other infertility drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ovulation rateTimepoint: Ovulation rate/Follicular response is defined as a follicular size following ovulation induction by letrozole of more than or equal to 17 mm on thirteenth day of menstrual cycle in which letrozole at a dose 2.5mg / 5mg / 7.5mg was given daily from day 2 to day 6 of cycle. If a follicular diameter of 14-15 mm is reached, then a repeat ultrasound is done after 2-3 days and a growing follicle (approximately 17 mm) is taken as response.
- Secondary Outcome Measures
Name Time Method Clinical pregnancy rate per cycleTimepoint: Clinical pregnancy rate per cycle is defined as the number of clinical pregnancies expressed per cycle of ovulation induction.;Clinical pregnancy rate <br/ ><br>Timepoint: Clinical pregnancy is defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive <br/ ><br>Clinical signs of pregnancy. In addition to intra-uterine pregnancy, it includes a clinically documented ectopic pregnancy;Cumulative pregnancy rateTimepoint: Cumulative pregnancy rate is defined as pregnancy rate following three ovulatory cycles;Miscarriage rateTimepoint: Miscarriage is defined as spontaneous loss of a clinical pregnancy before 24 completed weeks of gestational age.;Multiple gestation rateTimepoint: Multiple gestation is defined as a pregnancy with more than one embryo or fetus.