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: Health Condition 1: null- Female infertility

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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