FIN3001
Research type
Research Study
Full title
A Phase III assessor-blinded randomised parallel group multi-centre study to compare efficacy and safety of two r-hFSH formulations (AFOLIA vs Gonal-f®) in women for assisted reproductive treatment
IRAS ID
52593
Contact name
Yakoub Khalaf
Sponsor organisation
Finox AG
Eudract number
2010-019287-37
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
This study is intended to bring more treatment options to women needing assisted reproductive treatment. At present, Gonal-f© is widely used in women undergoing ovulation induction. Gonal-f© is a state-of -the-art, recombinant Follicle Stimulating Hormone, approved by the European Health Authorities and well characterized in its purity and biological activity. However, it is important to patients and to the public to make recombinant Follicle Stimulating Hormone available to a larger population of patients in a more economical and possibly a more convenient form. Therefore a very similar product ‘AFOLIA’ has been developed. This study will answer the question whether AFOLIA is just as safe and effective as Gonal-f©. The potential befits to the study participants will free medical treatment for their assisted reproduction treatment. The study involves treatments that would anyway be given to the participating patients as part of their normal therapy. Treatment cycles last on average 12 days and may be repeated as needed. Women 20 to 38 years old needing Assisted Conception would be eligible to participate. The study design is a simple comparison of the two products. One third of the patients receive Gonal-f©; the other two-thirds receive AFOLIA. The study is blinded: the people assessing the study results don’t know which of the two medicines were used by any patient. The sponsor of AFOLIA, Finox AG is funding this research. Patients will be recruited at The Assisted Conception Unit at Guy’s Hospital in London.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
10/H0806/48
Date of REC Opinion
30 Jul 2010
REC opinion
Further Information Favourable Opinion