ART FS1306 Study - Watson
Research type
Research Study
Full title
A Randomised, Parallel Group, Assessor-Blind, Multicentre Study to Compare the Safety and Efficacy of Watson rhFSH with Follitropin Alfa (GONAL-f) in Stimulating Multiple Follicular Development in Women Participating in an Assisted Reproductive Technology Program.
IRAS ID
152228
Contact name
Yacoub Khalaf
Contact email
Sponsor organisation
Activis pls,represented by its subsidiary Watso Laboratories
Eudract number
2013-003788-67
Research summary
This clinical study involves recombinant human follicle-stimulating hormone (rhFSH) for the treatment of infertility in women. The studied treatment is intended to increase the development of multiple follicles (egg containing capsules in the ovaries) in the ovulatory women participating in an Assisted Reproductive Technology (ART) program. The ART program used in this study is in vitro fertilisation (IVF). The objective is to demonstrate that patients treated with Actavis rhFSH will have a similar number of eggs retrieved as those patients treated with GONAL-f (follitropin alfa).
The treatment with rhFSH (either Actavis rhFSH or GONAL-f in this study) plus the additional administration of medications are all within the normal practice in an ART program.This study is a randomised, parallel group, assessor-blind multicentre study to compare the efficacy and safety of Actavis rhFSH with GONAL-f. Assessor-blind means that the fertility specialist will not know which product (i.e., Actavis rhFSH or GONAL-f) the patient is taking.
Several factors will determine if they are eligible for this study, including:
• Body mass index (BMI) should be = 18 and = 32 (BMI = Weight in kg divided by height in squared meter(s) or kg/m²).
• Both ovaries need to be normal.
• The male partner has acceptable sperm quality for ART or use of a donor’s sperm specimen.
• General health status of the patient is accepted for ART by the centre (fertility physician).
• The patient accepts and is willing to comply with the clinical study requirements.Female subjects who are diagnosed with infertility, 18 to 35 years of age (inclusive), and are eligible for the ART program will be divided at random into 2 groups. Depending on the group they are in the patients will be treated with one cycle of either Actavis rhFSH or GONAL-f for multiple-follicle development.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
14/LO/1058
Date of REC Opinion
21 Jul 2014
REC opinion
Further Information Favourable Opinion