Comparative study of Recombinant human menopausal gonadotrophin in treatment of infertility

A randomized, open label, assessor-blind, parallel group, multi centre Phase III study to compare the efficacy and safety of r-hMG and HP-hMG in subjects undergoing controlled ovarian stimulation for ART

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/11/010317

Enrollment

171

Registered

2017-11-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N970- Female infertility associated withanovulation Health Condition 2: null- Women undergoing infertility treatment (ART), aged 20 to 39 years, with less FSH and estradiol level

Interventions

Intervention1: r-HMG-recombinant human menopausal gonadotrophin: This is recombinant human menopausal gonadotrophin, will be given at dose of 150IU/day for 5 days, then at investigators discretion Con

Eligibility

Inclusion criteria

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

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. 13. history of other co morbid condition that prevent in participating in trial under investigators discretion. 14. history of addiction

Design outcomes

Primary

Measure	Time frame
To compare the number of oocytes retrieved in the groups receiving r-hMG and HP-hMGTimepoint: end of dosing IP	—

Secondary

Measure	Time frame
To compare the number of days of drug stimulationTimepoint: end of dosing of IP;to compare laboratory and imaging findingsTimepoint: stimulation day 6, on day of HCG administration;to compare laboratory and imaging parametersTimepoint: sitmuation day 6, On HCG administration;To compare the ongoing pregnancy rate,Timepoint: end of study;To compare the total dose of drug neededTimepoint: End of dosing of IP	—

Measure

Time frame

To compare the number of days of drug stimulationTimepoint: end of dosing of IP;to compare laboratory and imaging findingsTimepoint: stimulation day 6, on day of HCG administration;to compare laboratory and imaging parametersTimepoint: sitmuation day 6, On HCG administration;To compare the ongoing pregnancy rate,Timepoint: end of study;To compare the total dose of drug neededTimepoint: End of dosing of IP

—

Countries

India

Contacts

Public ContactDr Ganesh Divekar

Bharat Serums and Vaccines Ltd

ganesh.divekar@bharatserums.com022-4503456

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026