Intralipid and IVF Study
Research type
Research Study
Full title
Is the benefit of Intralipid infusion in IVF patients suffering from recurrent implantation failure due to modulation of Natural Killer Cells, platelet and endothelial function?
IRAS ID
159917
Contact name
Thozhukat Sathyapalan
Contact email
Sponsor organisation
Hull and East Yorkshire Hospital Trust
Eudract number
2014-002842-30
Research summary
Intralipid is a therapy used in IVF for patients who have problems with the embryo implanting in the womb. It is a solution made up soya oil. The theory is that it helps change the environment within the womb allowing the embryo to implant and allow the pregancy to proceed. The effect on the immune system following 3 infusions of Intralipid lasts between 6 and 9 weeks on average.
This research project is to assess whether there is a relationship between the ratio of cetain types of immune cells (Natural killer cells) and white cells (platelet)prior to and throughout the treatment with Intralipid infusions. Does this possible relationship change throughout the treatment with Intralipid, and is there any effect on pregnancy rates following the Intralipid infusion?
Currently intralipid is being used in clinical practice according to this protocol. There is will be no change in clinical practice other than additional blood samples being taken at the beginning and at the end of each infusion. Each research participant will have 3 infusions of Intralipid. The first dose of Intralipid is administered during the stimulation of the ovary phase of the IVF cycle. The second dose is administered around the time of embryo transfer. The third dose of Intralipid is administered around the time immediately after a positive pregnancy test.
A control group has been included which will consist of patients undergoing their first cycle of IVF. This group of patients has been included to look at any IVF effect on Natural Killer cells, platelet and endothelial function throughout their cycle. They will have their bloods taken at the same time in their IVF cycle as when the intralipid group are having their infusions. The first blood sample will be taken during the stimulation of the ovary phase of the IVF cycle, the second around the time of the embryo transfer and the final taken if the patient has a positive pregnancy test.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1082
Date of REC Opinion
14 Aug 2014
REC opinion
Further Information Favourable Opinion