Health Condition 1: null- Female undergoing for treatment of Infertility
Conditions
Interventions
Intervention1: R-TPR-013: Dose- 0.25 mg, Frequency- R-TPR-013 will be
administered at the
dose of 250 μg as per
individualâ??s response, Mode of Administration- Subcutaneous
Control Intervention1: NA
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of R-TPR-013. Timepoint: Assessment of oocytes post R-TPR-013 administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safetyTimepoint: Evaluation of safety will be based on incidence of treatment-emergent adverse events, abnormal clinical as well as laboratory results from baseline to end of the study. | — |
Countries
India
Contacts
Public ContactDr Sanjeev Hegde
Reliance Life Sciences Pvt Ltd
Outcome results
None listed