Comparative study of Recombinant human menopausal gonadotrophin in treatment of infertility
- Conditions
- Health Condition 1: N970- Female infertility associated withanovulationHealth Condition 2: null- 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
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 309
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
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
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-hMGTimepoint: end of dosing IP
- Secondary Outcome Measures
Name Time Method 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