A clinical trial to study the effect of R-TPR-020 in patients undergoing treatment for infertility.
- Conditions
- Health Condition 1: null- Infertile females undergoing for controlled ovarian hyperstimulation (COH).or patients undergoing treatment for Polycystic ovarian syndrome (PCOS)
- Registration Number
- CTRI/2009/091/000888
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
1.Female subjects age 18 years to 40 years (both inclusive) at the time of screening.
2.Infertile females of couples undergoing for controlled ovarian hyperstimulation (COH) or patients undergoing treatment for Polycystic ovarian syndrome (PCOS).
3.Patients with BMI between 18-29 kg/m2 (both inclusive) at the time of screening.
1.History of clinically significant endocrine related abnormality
2.History / presence of undiagnosed vaginal bleeding
3.History of primary ovarian failure
4.Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
5.History of clinically significant diseases, e.g. epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease
6.Use of hormonal preparations within one month prior to the start of FSH with the exception of thyroid medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method