Comparative study of Recombinant human menopausal gonadotrophin in treatment of infertility

Phase 3

Active, not recruiting

• Conditions: Female infertility associated withanovulation, Women undergoing infertility treatment (ART), aged 20 to 39 years, with less FSH and estradiol level ,

• Registration Number: CTRI/2017/11/010317
• Lead Sponsor: Bharat serums and Vaccines ltd

Brief Summary

This is a prospective, randomized, open label, parallel group, multi-center Phase III study to compare the efficacy and safety of **r-hMG** and **HP-hMG** in subjects undergoing controlled ovarian stimulation for ART. Women who are indicated to undergo ART for infertility, aged between 20 to 39 years of age, with no uterine or endocrinal abnormalities and willing to participate in the trial will be enrolled after fulfilling the eligibility criteria. The primary endpoint- number of oocyte retrieved will be captured once the IP administration is completed. The rate of pregnancy, laboratory parameters, and imaging findings will be compared between two groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-03
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Female
• Target Recruitment: 171

Inclusion Criteria

• Subject has an indication for ART using COS.
• regular menstural cycle.
• FSH level less Estradiol level less, AFC of 10- 25 BMI more than 18.5 and less than 30 kg/m2.

Exclusion Criteria

• 1 history of >2 successive ART cycles without clinical pregnancy 2.
• history of any endocrine abnormality 3.
• history of OHSS 4.
• documented PCOS 5.
• having Ovarian abnormality 6.
• documented severe endometriosis 7.
• having submucosal fibroid 8.
• history of extrauterine pregnancy in past 3 months 9.
• History of miscarriages 10.
• Poor response to gonadotropin treatment 11.
• Positive HIV, Hepatits B, C 12.
• Known case of allergic, hypersensitive, to r-hmg, or its excipients.
• history of other co morbid condition that prevent in participating in trial under investigators discretion.
• history of addiction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the number of oocytes retrieved in the groups receiving r-hMG and HP-hMG	end of dosing IP

Secondary Outcome Measures

Name	Time	Method
To compare the ongoing pregnancy rate,	end of study
To compare the total dose of drug needed	End of dosing of IP
To compare the number of days of drug stimulation	end of dosing of IP
to compare laboratory and imaging parameters	sitmuation day 6, On HCG administration
to compare laboratory and imaging findings	stimulation day 6, on day of HCG administration

Trial Locations

Locations (16)

Ajanta Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

All India Institute Of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Apollo Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Choithram Hospital & Research Centre; 🇮🇳 Indore, MADHYA PRADESH, India

CK Birla Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Deenanth Mangeshkar Hospital and Research Cente; 🇮🇳 Pune, MAHARASHTRA, India

Fortis hospital Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

Inamdar Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Maharaja Agrasen Hospital; 🇮🇳 Delhi, DELHI, India

Milann -A unit of BACC Healthcare pvt. Ltd; 🇮🇳 Bangalore, KARNATAKA, India

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Ajanta Research Centre

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Geeta Khanna

Principal investigator

ivfajanta@gmail.com