A clinical trial to study the effect of R-TPR013 in patients undergoing treatment for infertility
- Conditions
- Health Condition 1: null- Female undergoing for treatment of Infertility
- Registration Number
- CTRI/2010/091/001063
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 102
1. Patients with BMI between 18-29 kg/m2 (both inclusive) at the time of screening.
2. Female subjects age 18 years to 37 years (both inclusive) at the time of screening.
3. Infertile females of couples undergoing for controlled ovarian hyperstimulation (COH)
1. History of clinically significant endocrine related abnormality 2. Any ovarian and/or abdominal abnormality interfering with ultrasound examination 3. History of clinically significant diseases e.g. epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease or PCOS 4. Subjects positive for HIV, HBsAg, HCV. 5. Subject participation in another clinical trial 30 days prior to administration of IP. 6. Any other condition which investigator feels would pose a significant hazard to subject if IP is administered. 7. Subject with history of alcohol or drug abuse within 12 months prior to signing informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of R-TPR-013. <br/ ><br>Timepoint: Assessment of oocytes post R-TPR-013 administration
- Secondary Outcome Measures
Name Time Method Evaluation of safetyTimepoint: Evaluation of safety will be based on incidence of treatment-emergent adverse <br/ ><br>events, abnormal clinical as well as laboratory results from baseline to end of the <br/ ><br>study.