A clinical trial to see the effects, safety and patient compliance of two drugs Newmon-R™ pre filled syringe and Gonal-F® pen in infertile women undergoing IVF treatment

Phase 4

Completed

• Conditions: Female infertility

• Registration Number: CTRI/2013/06/003749
• Lead Sponsor: LG Life Sciences India Pvt Ltd

Brief Summary

This study is a multi-centre, open label, randomised, parallel active controlled phase IV study to compare and evaluate the clinical efficacy, safety and patient compliance of Newmon-Râ„¢ (rhFSH) Pre-filled Syringe with Gonal-F® Pen in Infertile Women undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies. All patients treatment will be followed according to long gonadotropin releasing hormone agonist protocol. 120 patients will be enrolled and data will be analysed using appropriate statistical tests.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-30
• Last Update Posted: 2014-12-29

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1.Infertile women between 20-39 years of age 2.Basal FSH less than 10 IU/L 3.Regular menstrual cycles of 24to 35 days of duration 4.Antral size follicles more than 5 5.Normal functional ovaries and uterus 6.Willing to give voluntary written consent.

Exclusion Criteria

• 1.Uterine myoma (fibroids) 2.Subjects with primary ovarian failure, uncontrollable hyperthyroidism or secondary adrenal insufficiency 3.Body Mass Index more than 30 kg/m2 4.Subjects with previous history of ovarian hyperstimulation syndrome in the previous IVF cycles 5.More than 3 previously consecutive unsuccessful IVF cycles 6.Any significant systemic disease, endocrine or metabolic abnormalities 7.Tumors of the ovary, breast, uterus, hypothalamus or pituitary gland 8.Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD) 9.HIV or syphilis positive subjects 10.History of alcohol or drug addiction 11.Subjects smoking more than 5 cigarettes per day 12.History of hypersensitivity to rhFSH or other pharmaceutical excipients of this drug 13.Positive serum pregnancy test 14.Undiagnosed vaginal bleeding 15.Subjects unable to understand the objectives, methods, etc.
• of this clinical study and are unable to comply with the study procedures 16.Participation in any other clinical trial within 3 months of registering in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total number of oocytes retrieved	At the end of one IVF cycle

Secondary Outcome Measures

Name	Time	Method
Total administration dosage of rhFSH	Duration of rhFSH stimulation

Trial Locations

Locations (5)

AMRI Medical Centre; 🇮🇳 Kolkata, WEST BENGAL, India

Institute of Reproductive Medicine; 🇮🇳 Kolkata, WEST BENGAL, India

Kaival Hospital; 🇮🇳 Anand, GUJARAT, India

Nadkarni Hospital & Test Tube Baby Centre; 🇮🇳 Valsad, GUJARAT, India

Nadkarni’s 21st Century Hospitals & Test Tube Baby Centre; 🇮🇳 Surat, GUJARAT, India

AMRI Medical Centre

🇮🇳Kolkata, WEST BENGAL, India

Dr Sudip Basu

Principal investigator

033-66228000

sbasu64@gmail.com