Effect of Foligraf� and Gonal-F® in assisted reproductive technology

Phase 3

• Conditions: Health Condition 1: N970- Female infertility associated withanovulationHealth Condition 2: null- Women between age 20-39 years (both inclusive) who are referred for controlled ovarian stimulation as part of Assisted reproductive technique

• Registration Number: CTRI/2016/06/006993
• Lead Sponsor: Bharat Serums and Vaccines Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the number of oocytes retrieved in both the groups receiving r-hFSHTimepoint: once - at oocyte retrival