A clinical trial to see the effects and safety of two drugs IVF-Mâ„¢ (Menotropin)and MenopurÂ® (Menotropin) in Infertile Women undergoing IVF treatment

Phase 4

Completed

Conditions: Female infertility

Registration Number: CTRI/2012/05/002656

Lead Sponsor: LG Life Sciences India Pvt Ltd

Brief Summary: This study is a multi-centre, open label, randomized, parallel active controlled phase IV pilot study to compare and evaluate the clinical efficacy and safety of IVF-Mâ„¢ with MenopurÂ® in Infertile Women undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies. All patientsâ€™ treatment will be followed according to long gonadotropin-releasing hormone agonist protocol. 60 patients will be enrolled from two sites in India. Data will be analysed using appropraite statistical tests.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

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

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	At the end of one in vitro fertilization cycle

Secondary Outcome Measures

Name	Time	Method
Total administration dosage and duration of menotropin stimulation	Serum estradiol level on the day of hCG

Trial Locations

Locations (2): Institue of Kidney Diseases & Research Centre, Institute of Transplantation Sciences (IKDRC-ITS)
🇮🇳
Ahmadabad, GUJARAT, India
Institute of Reproductive Medicine (IRM)
🇮🇳
Kolkata, WEST BENGAL, India
Institue of Kidney Diseases & Research Centre, Institute of Transplantation Sciences (IKDRC-ITS)
🇮🇳Ahmadabad, GUJARAT, India
Dr Vineet Mishra
Principal investigator
079-22685600
vvmivf@gmail.com