etrozole in combination with gonadotrophins versus gonadotrophins alone in infertile couple undergoing intrauterine inseminatio
Phase 2
Completed
- Conditions
- Health Condition 1: N979- Female infertility, unspecified
- Registration Number
- CTRI/2021/01/030596
- Lead Sponsor
- Jawaharlal Nehru Medical Collage
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1-BMI less than 35 kg/m2.
2-Normal overian reserve.
3-At least one patent fallopian tube.
4-Woman willing and complying with scheduled visits , treatment plans, laboratory tests & given written informed consent.
Exclusion Criteria
1-Female BMI > 35 kg/m2
2-Bilateral tubal blockage
3-Uterine anomaly , fibroid
4-Hydrosalpingx
5-Poor overian reserve
6-Severe male factor subfertility ( < 10 million progressive motile sperm cells per sample in repeated semen analyses)
7-Severe medical disorder ( Diabetes Mellitus, Renal disease, Liver disorder)
8-Known allergy to Letrozole or Gonadotropin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Growth of follicle <br/ ><br>2.Length of follicular phase <br/ ><br>3.Number of follicles on day of trigger <br/ ><br>4.Diameter of follicle at time of trigger <br/ ><br>5.Thickness of endometrium <br/ ><br>6.Endometrial pattern (triple layer) <br/ ><br>Timepoint: Day 7 to day 10 of menstrual cycle
- Secondary Outcome Measures
Name Time Method 1.Clinical pregnancy rate <br/ ><br>2.Ongoing pregnancy rate <br/ ><br>3.Cost effectiveness <br/ ><br>4.Complication rate(eg.OHSS) <br/ ><br>5.Multiple pregnancy rate <br/ ><br>6.Side effect of drugs <br/ ><br>Timepoint: 2 years