Health Condition 1: N97- Female infertility
Conditions
Interventions
Intervention1: HP-hMG (manufactured by Bharat Serums and Vaccines Ltd):
150 IU (225 IU, if age more than 35 years) subcutaneously for at least first 5 days of treatment starting on day 2-3 of menstru
Sponsors
Bharat serums and Vaccines ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Ganesh Divekar
Bharat Serums and Vaccines Ltd
Outcome results
None listed