Health Condition 1: N970- Female infertility associated withanovulation Health Condition 2: null- Women between age 20-39 years (both inclusive) who are referred for controlled ovarian stimulation as part of Assisted reproductive technique
Conditions
Interventions
Intervention1: Foligrafâ?¢: fixed dose of 225 IU/day, SC, daily, for 5 days. further dosage will be adjusted till adequate follicular development
Control Intervention1: Gonal-F®: fixed dose of 225 IU
Sponsors
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Woman, between 20 and 39 years of age ; 2.Subject has an indication for ART using COS; 3.Subject has a regular menstrual cycle of 21-35 days (both inclusive); 4.Subject has normal FSH level 5.Subject has normal estradiol levels 6.Subject has good AFC 7.Subject has a normal body mass index 8.Subject has results of clinical laboratory tests (haematology, blood chemistry, and urinalysis) within normal reference range, or outside the reference range 9.Subject and her partner are willing to provide written informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Subject has history of successive ART cycles 2. Subject with history of any endocrine abnormality 3. Subject with a history of ovarian hyperresponse 4. Subject with documented polycystic ovarian syndrome 5. Subject with only one ovary or ovarian abnormality 6. Subject with documented severe endometriosis 7. Subject with submucosal fibroids or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation 8. Subject with a history of extrauterine pregnancy 9. Subject with history of poor response to gonadotropin treatment in the previous ART cycle; 10. Subject with history of miscarriages 11. Subject who have tested positive for HIV, Hepatitis B or Hepatitis C at screening; 12. Subject known to be allergic, hypersensitive, or intolerant to any of the preparations of r hFSH 13. Subject with contraindications to the use of gonadotropins 14. Subject with a history of epilepsy, thrombophilia, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, auto-immune disease or any active infection, requiring treatment which at the investigatorâ??s discretion might interfere with the study; 15. Subject with history of malignancy; 16. Subject who smokes or has stopped smoking within the last 3 months prior to screening; 17. Subject with a history of alcohol or drug abuse 18. Subject who has received any treatment that can have teratogenic effect or affect ovulation 19. Subject who has received an investigational product or has used an invasive investigational medical device within 30 days before the planned first dose of the study drug; or is currently enrolled in an investigational study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the number of oocytes retrieved in both the groups receiving r-hFSHTimepoint: once - at oocyte retrival | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects reporting any adverse eventTimepoint: through out the study duration;Percentage of subjects with dose reduction due to imminent OHSSTimepoint: end of stimulation;To compare number and quality of embryosTimepoint: AT embryo transfer;To compare quality of oocytesTimepoint: at oocyte retrieval;To compare the cycle cancellationTimepoint: prior to oocyte retrieval;To compare the days of r-hFSHTimepoint: At end of stimulation;To compare the endocrinological parametersTimepoint: At baseline and on the day of HCG abdministration;To compare the endometrial thicknessTimepoint: On Day 6;To compare the number and size distribution ofTimepoint: On Day 6 of stimulation;To compare the number of oocytes retrieved in subjects 35 and â?¥ 35 years of ageTimepoint: At oocyte retrieval;To compare the percentage of subjects requiring change in dose from Day 6 onwardsTimepoint: at end of stimulation;To compare the pregnancy rateTimepoint: 12 weeks after Embryo transfer ;To compare the total dose of r-hFSHTimepoint: at the end of stimulation;To evaluate the immunogenicity of Foligrafâ?¢Timepoint: At baseline, 4 weeks after first dose of r FSH and end of study | — |
Countries
India
Contacts
Public ContactDr Ganesh Divekar
Bharat Serums and Vaccines Ltd.
Outcome results
None listed