000004 Ovarian stimulation in women using infertity treatment
Research type
Research Study
Full title
A randomised, controlled, assessor-blind, parallel groups, multicentre, multinational trial comparing the efficacy and safety of FE 999049 with follitropin alfa (GONAL-F) in controlled ovarian stimulation in women undergoing an assisted reproductive technology programme
IRAS ID
125456
Contact name
Stuart Lavery
Contact email
Sponsor organisation
Ferring Pharmaceuticals A/S
Eudract number
2013-001669-17
Research summary
This trial is for women undergoing infertility treatment. Infertility is when a couple cannot conceive (get pregnant) despite having regular unprotected sexual intercourse.\n\nControlled ovarian stimulation with hormone preparations is used to induce the development of multiple egg sacs (follicles) allowing more eggs to be retrieved in women undergoing fertility treatment. \n\nFE999049 is a new recombinant follicle-stimulating hormone (FSH) which is being developed by Ferring Pharmaceuticals for this purpose. FE999049 is produced from a human cell line in contrast to the current commerically available FSH products which are made from a non-human cell.\n\nThe main aim of this trial is to show that the effect of this new treatment, FE999049, is not worse than that of an active control by more than a specified margin.\n\nA secondary aim will be comparing the clinical benefits of FE 999049 in its novel dosing regimen to those of GONAL-F with respect to the capacity for beneficial change and safety.\n\nIt is planned to randomise 1,150 subjects, aged 18-40 years, of whom 575 will be randomised to FE 999049 and 575 will be randomised to GONAL-F. It is estimated that up to 1,400 subjects should be screened to achieve 1,150 subjects eligible for randomisation.\n\nThis study will be performed in approximately 24 sites in 7 countries. The maximum period of exposure to FE 999049 or GONAL-F is 20 days.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0208
Date of REC Opinion
29 Aug 2013
REC opinion
Further Information Favourable Opinion