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

Phase 3

Completed

• Conditions: 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

This is a prospective, multicentric, open label, single arm clinical trial to evaluate the safety and efficacy of R-TPR-020 in infertile females undergoing controlled ovarian hyperstimalation or patients undergoing treatment for polycystic ovarian syndrome. Total 45 subjects will be enrolled across the centers in India. The primary outcome measure will be the number of oocyte retrived post 36 hours of beeta hCG administration. Study duration of study will be of 7 month (6 month recruitment, 2 weeks screening & 2 weeks treatment)

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-24
• Study Completion: 2010-06-03
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 45

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

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
To assess the efficacy of R-TPR-020 in Hyper stimulation of ovaries.	Mean number of oocytes retrieved 36 hours post rhCG administration

Secondary Outcome Measures

Name	Time	Method
1.Assessment of oestradiol levels on the day of rhCG administration	2.Evaluation of safety

Trial Locations

Locations (11)

Dr. Patil's Fertility & Endoscopy Clinic; 🇮🇳 Bangalore, KARNATAKA, India

Dr.Patil's Fertility & endoscopy clinic; 🇮🇳 Bangalore, KARNATAKA, India

Gynaec World Assisted Fertility Unit; 🇮🇳 Mumbai, MAHARASHTRA, India

Indraprasth Apollo Hospital; 🇮🇳 Delhi, DELHI, India

Mayflower Women's Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Nashik Women's Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Pune Fertility Centre; 🇮🇳 Pune, MAHARASHTRA, India

ReGenesis Centre for Assisted Reproduction Endoscopy and Fetal Medicine; 🇮🇳 Mumbai, MAHARASHTRA, India

Reproductive Medicine, BACC Health Care Pvt. Ltd.; 🇮🇳 Bangalore, KARNATAKA, India

Sai Kiran Hospital & Kiran Infertility Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

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Dr. Patil's Fertility & Endoscopy Clinic

🇮🇳Bangalore, KARNATAKA, India

Dr. Madhuri Patil

Principal investigator

drmadhurip@rediffmail.com