IBSA Study 13EU/FSH01
Research type
Research Study
Full title
Randomised clinical trial comparing highly purified FSH formulation (Fostimon®) and recombinant FSH (Gonal-F®) in GnRH-antagonist controlled ovarian hyperstimulation cycles
IRAS ID
137979
Contact name
Gillian Lockwood
Contact email
Sponsor organisation
IBSA Institut Biochimique SA
Eudract number
2013-002482-19
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
This is a clinical research project sponsored and funded by IBSA Institut Biochimique S.A.
Follicle stimulating hormone (FSH) is needed for normal maturation of an egg in a follicle. This hormone has been used for over 35 years in women with fertility problems.
In order to collect information on the effectiveness of the trial substance Fostimon® in this study two different FSH peparations Fostimon® and Gonal-F® will be compared.
Subjects will be put by chance (randomly) into one of the treatment groups (Fostimon® or Gonal-F®). This is an ’Investigator blind’ study which means that in order not to influence in any way the evaluation of the study drugs, the doctor assessing symptoms will not know to which treatment the patient is randomised.
The study will assess clinical pregnancy rate per stimulated cycle, per oocyte (egg) retrieval and per embryo (fertilised egg) transfer. Also quality of oocyte and embryo will be evaluated.
The research study consists of 8 Visits (Screening Visit 1, Treatment Phase Visits 2-7, Final Visit 8) and Follow-up.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
13/SC/0572
Date of REC Opinion
24 Dec 2013
REC opinion
Further Information Favourable Opinion