Overview

Recombinant Follicle-stimulating Hormone in Treatment for Infertility

Status:
Not yet recruiting
Trial end date:
2023-11-30
Target enrollment:
Participant gender:
Summary
This is a randomized multi-centre, assessor-blind, parallel-group study to be conducted in 250 women in the age group of 20 to 39 years (both inclusive), who are indicated to undergo COS as part of assisted reproductive technology (ART). The participant will receive r-hFSH, fixed-dose for 5 days, and day 6 onwards the dose may be adjusted for a single cycle of COS followed by ART procedures, and post-ART follow-up for ongoing pregnancy. The primary and secondary outcomes will be captured on days as per protocol. Adverse events will be noted for safety evaluation.
Phase:
Phase 3
Details
Lead Sponsor:
Bharat Serums and Vaccines Limited
Treatments:
Follicle Stimulating Hormone
Hormones