Comparative study between two brands of human menopausal gonadotropin in infertility patients
- Conditions
- Health Condition 1: N97- Female infertility
- Registration Number
- CTRI/2019/10/021795
- Lead Sponsor
- Bharat serums and Vaccines ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Subject has an indication for assisted reproductive technique
2. History of regular menstrual cycles
3. Has good ovarian reserve
4. Has an AFC count 10-25
5. Has a body mass index between 18 to 30 kg/m2
6. Has laboratory tests results within normal reference range
7. Subject and her partner are willing to provide written informed consent and comply with study procedures
1. Subject has a history of >2 ART cycles
2. Has a history of any endocrine abnormality, with documented hormone levels outside the reference range
3. Has a history of ovarian hyper-response or OHSS
4. With documented polycystic ovarian syndrome
5. With only one ovary or ovarian abnormality
6. With documented severe endometriosis or hydrosalphinx
7. With submucosal fibroids
8. WIth a history of extra-uterine pregnancy
9. with a history of poor response to gonadotropin treatment in previous ART
10. With a history of > 3 miscarriages
11. Who have tested positive for HIV, Hepatitis B, or Hepatitis C
12. Who is allergic to preparations of HP-HMG or menopur or its excipients
13. with contraindication of use of gonadotropins or GnRH antagonists
14. With a history of epilepsy, thrombophilia, cardiovascular, gastrointestinal hepatic, renal pulmonary, auto-immune disease or any active infection
15. With history of malignancy
16. Who smokes or stopped smoking within 3 months from screening
17. with history of alcohol or drug abuse
18. who has received any treatment known to affect ovulation or known or suspected to be teratogenic
19. who has recieved an IP or have used invasive investivational medical devise within 30 days of enrolment in to this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare the number of oocytes retrieved in both the groupsTimepoint: At oocyte pick up will be approximately 36 hours post HCG administration
- Secondary Outcome Measures
Name Time Method Endometrial thickness (in mm)Timepoint: HCG administration;Number of days required for achieving maturation of folliclesTimepoint: HCG administration;Proportion of good quality embryosTimepoint: Embryo transfer;Proportion of mature oocytesTimepoint: Oocyte pickup;Proportion of subject who achieve clinical pregnancyTimepoint: 4 weeks post ET;Proportion of subject who had cycle cancellationTimepoint: Any time during the study;Proportion of subject who have ongoing pregnancyTimepoint: 12 weeks after ET;Proportion of subjects requiring dose adaptationTimepoint: day 6 onwards;Serum levels of Estradiol, LH and progesteroneTimepoint: HCG administration;The number and size of follicles measuring 11mm, 11-14 mm, 15 mm, 16 mm, 17 mm and equal to or more than 18 mmTimepoint: HCG administration;Total dose of HP-hMG received by subjectTimepoint: HCG administration