A clinical trial to see the effects and safety of two drugs IVF-M� (Menotropin)and Menopur® (Menotropin) in Infertile Women undergoing IVF treatment

Phase 4

Completed

• Conditions: Health Condition 1: null- Female infertility

• Registration Number: CTRI/2012/05/002656
• 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: 60

Inclusion Criteria

Regular menstrual cycles of 24 to 35 days of duration, Normal basal FSH and LH during the early follicular phase, antral size follicles more than 5, Normal functional ovaries and uterus, Infertility due to any of the following factors: tubal factor, endometriosis (stage 1 or 2), male factor or unexplained factor, 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 30 kg/m2

4.Subjects with previous history of ovarian hyperstimulation syndrome (OHSS) 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.Intracranial bleeding

10.An organic intracranial lesion such as pituitary tumor

11.HIV or syphilis positive subjects

12.History of alcohol or drug addiction

13.Subjects smoking more than 5 cigarettes per day

14.History of hypersensitivity to hMG or other pharmaceutical excipients of this drug

15.Positive serum pregnancy test

16.Undiagnosed vaginal bleeding

17.Subjects unable to understand the objectives, methods, etc. of this clinical study and are unable to comply with the study procedures

18.Participation in any other clinical trial within 3 months of registering in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified