Extrait

Background and study aims In order for a woman to become pregnant, the fertilized egg must attach (implant) itself to the lining of the womb. In vitro fertilization (IVF) is a technique used to help people with fertility problems to have a baby. During IVF, couples donate their own sperm and eggs (or use sperm and eggs from a donor). The egg is fertilized by the sperm outside of the body to create an embryo and then returned to the woman’s womb to develop. Although IVF has become more and more successful in recent years, there is still a relatively high failure rate. Recent studies have shown that a natural chemical released by white blood cells called Granulocyte macrophage colony-stimulating factor (GM-CSF) could be directly related to the success of IVF. In normal pregnancies, levels of this chemical have been found to be higher, suggesting that it plays a role in implantation and embryo development. Embryogen (Origio) is a ready-to-use growth medium (environment) which contains GM-CSF. Some previous studies have shown that using this medium in the fertilization of eggs in IVF treatment could help to improve the chance of pregnancy in women who have previously had a miscarriage. The aim of this study is to find out whether using Embryogen in the IVF treatment of women who have had previous unsuccessful IVF treatment could help to improve the chance of pregnancy. Who can participate? Women aged between 25 and 45, who have had at least one previous IVF treatment that did not result in pregnancy. What does the study involve? Participants are all treated using hormonal injections between day 12 and 20 of their menstrual cycle to stimulate their ovaries to release eggs (oocytes). They are then given further hormone treatment and the eggs are retrieved using a needle (to such them out of the ovary). The participants are then randomly allocated to one of two groups. For those in the first group, the best quality eggs are selected and are fertilized using Embryogen as the growth medium. For those in the second group, the best quality eggs are selected and are fertilized using ISM1 as the growth medium (usual growth medium used). Fertilization for all eggs is done using Intracytoplasmic sperm injection (ICSI), in which a single sperm is injected directly into each egg. Two to three days later, the embryos are then implanted into the respective participants’ wombs. After thirty days, the amount of embryos that successfully attached to the womb lining (implantation rate) and the amount of women who became pregnant are measured for participants in both groups. What are the possible benefits and risks of participating? There are no direct benefits or risks involved with taking part in this study. Where is the study run from? Gynepro Medical S.R.L. (Italy) When is the study starting and how long is it expected to run for? January 2012 to December 2016 Who is funding the study? Gynepro S.R.L. (Italy) Who is the main contact? Dr Lodovico Parmegiani

Critère d'inclusion

• Intracytoplasmic sperm injection (ICSI) and embryo culture

Liens

• ictrp
• isrctn