NCT05266924: REFRESH

Recombinant Follicle-stimulating Hormone in Treatment for Infertility

Status unknown Phase 3 Last updated 1 August 2023

What this trial tests

Phase 3 trial testing Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen in Female Infertility in 250 participants. Status unknown.

Timeline

23 July 2022

Primary endpoint
31 August 2023

30 November 2023

Quick facts

Lead sponsor	Bharat Serums and Vaccines Limited
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	250
Start date	23 July 2022
Primary completion	31 August 2023
Estimated completion	30 November 2023
Sites	1 location across India

Drugs / interventions tested

• Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen

Conditions studied

• Female Infertility — all drugs for Female Infertility →

Sponsor

Bharat Serums and Vaccines Limited — full company profile →

Who can join

Adults 20 to 39, female only, with Female Infertility. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.