Pharmacogenomics trial of GONAL-f® in ART
Research type
Research Study
Full title
A Phase IV multinational, multicenter, exploratory pharmacogenomics trial to test the importance of identified genetic markers, and potentially identify new markers of various ovarian responses to GONAL-f® treatment in women undergoing assisted reproduction technology (ART)
IRAS ID
7217
Contact name
Yacoob Khalaf
Contact email
Sponsor organisation
Merck Serono International, A branch of Laboratoires Serono S.A.
Eudract number
2008-001174-33
ISRCTN Number
0000000000000
Clinicaltrials.gov Identifier
0000000000000
Research summary
This is a multinational, multicenter pharmacogenomics study in infertile women. Pharmacogenomics is the study of the relationship between a persons hereditary material (genes) and their reaction to medications. In other branches of medicine not all individuals react the same way to the same medication and some medications are effective in some individuals and not in others. Pharmacogenomics has been able to demonstrate that genes are responsible for many of these differences between individuals.
Specifically, this study will evaluate the different responses of infertile women to the infertility drug GONAL f® and relate it to the woman’s genes. The hope is that in the future infertility specialists will have a simple test to identify these genes, identify women who will respond well and those who will not and therefore allow the specialist to adapt the drug treatment of their patients thus making treatment more effective.
This study that is being conducted by Merck Serono International, is a one-day, single blood sampling in women who have previously been treated with GONAL f®. No drugs will be given nor will any physical or laboratory examinations be conducted. Based on the results of the previous treatment a relationship will be sought with the patient’s genes. Patients will be asked to provide a blood sample at any given day of the menstrual cycle or pregnancy.
A total of 1500 female patients will be recruited into this study.
REC name
Wales REC 3
REC reference
09/MRE09/6
Date of REC Opinion
2 Mar 2009
REC opinion
Further Information Favourable Opinion