Immune response in repeated cycles of controlled ovarian stimulation
Research type
Research Study
Full title
A controlled, assessor-blind, parallel groups, multicentre, multinational trial evaluating the immunogenicity of FE 999049 in repeated cycles of controlled ovarian stimulation in women undergoing an assisted reproductive technology programme
IRAS ID
132976
Contact name
Stuart Lavery
Contact email
Sponsor organisation
Ferring Pharmaceuticals A/S
Eudract number
2013-001616-30
Research summary
This trial 000071 is for women undergoing infertility treatment. Infertility is when a couple cannot conceive (get pregnant) despite having regular unprotected sexual intercourse.\n\nThis is a follow-up to controlled ovarian stimulation trial 000004 which was only 1 cycle of the treatment and a fixed dose of the ovarian stimulant. Ferring Pharmaceuticals is inviting women who participated in the trial 000004 to participate in trial 000071 which will be a subsequent 2 cycles of controlled ovarian stimulation and the dose will depend on how they responded to treatment in the previous cycle.\n\nControlled ovarian stimulation with hormone preparations is used to induce the development of multiple egg sacs (follicles) allowing a number of eggs to be retrieved in women undergoing fertility treatment. \n\nThe main purpose of this follow-up clinical research trial is to assess the immune response of FE 999049 and a commercially available recombinant follicle-stimulating hormone (rFSH) product (GONAL-F). The results of the trial are anticipated to be the foundation for approval of FE 999049 to be used in women undergoing controlled ovarian stimulation.\n\nThis study will be performed in approximately 24 sites in 11 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/0209
Date of REC Opinion
29 Aug 2013
REC opinion
Further Information Favourable Opinion