A clinical trial to study the effect of R-TPR-020 in patients undergoing treatment for infertility.

Prospective, multicentric, open label, clinical study to evaluate efficacy and safety of R-TPR-020 in patients undergoing treatment for infertility.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000888

Enrollment

Registered

2009-12-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Infertile females undergoing for controlled ovarian hyperstimulation (COH). or patients undergoing treatment for Polycystic ovarian syndrome (PCOS)

Interventions

Intervention1: R-TPR-020: Dose:200 IU, Route of Administration:Subcute, Frequency & Duration:Daily till atleast 3 follicles of size 17 mm are developed. Control Intervention1: Not Applicable: Not Appl

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of R-TPR-020 in Hyper stimulation of ovaries.Timepoint: Mean number of oocytes retrieved 36 hours post rhCG administration	—

Secondary

Measure	Time frame
1.Assessment of oestradiol levels on the day of rhCG administration 2.Evaluation of safety Timepoint: 1.The mean oestradiol levels on the day of rhCG administration 2.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.

sanjeev.hegde@relbio.com02267678208

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026