Extrait

Background and study aims Male infertility accounts for almost half of all referrals to the IVF clinic for assisted conception. In many cases, the male sperm are present but are either unable to fertilise his partner's egg or the embryo fails to implant or even miscarries at a later stage. It is possible to inject sperm directly into the egg [Intracytoplasmic Sperm Injection (ICSI)] and for pregnancies to be achieved as a result. Unfortunately, however, although this method is very often successful at fertilising the egg, achieving a viable pregnancy is far less successful. It is estimated that on average, once transferred to his partner's uterus, less than a quarter of all fertilised eggs will implant and develop into a baby to term. Recently, a new method for sperm selection has been developed and initial results suggest it may help pregnancy outcomes. The method relies on selecting sperm by their ability to stick to a naturally occurring substance hyaluronan that is normally found close to the surface of the egg. This material can be coated on to a special plate and if the male sperm is allowed to swim or flow over the material, the 'best' sperm will bind to the coating and can then be easily picked for injection. This study aims to show that replacing the usual sperm selection step with this method can significantly improve the live birth rate. This study also aims to assess other factors including pregnancy rate, live birth rate and pregnancy loss. Who can participate? This study aims to recruit 3730 couples undergoing ICSI treatment, aged over 18 years. What does the study involve? Couples will be randomly allocated to one of two groups: the intervention group where the specialists will select the sperm using hyaluronan binding for the ICSI procedure; the control group where they will select the sperm using the standard practice. The group to which the couple are allocated to will be decided by a process called randomisation, which is like a coin toss. The study does not involve any additional procedures, we will only collect the treatment outcomes for all participating females. At the end of the study, we will compare the live birth rate in both groups. We will also look at the miscarriage rate and clinical pregnancy rate, which reflects how many treated women with embryo(s) transferred into their womb, proceeded to pregnancy confirmed by detecting a fetal heartbeat or fetal sac. What are the possible benefits and risks of participating? There will be no immediate direct benefit to those taking part. This research may, however, in time improve general ICSI treatment and its outcome rates. ICSI is routinely performed and as might be expected from a naturally occurring substance that is present throughout the body, there have been no reported risks with using hyaluronan. Hyaluronan-coated plates are already approved for clinical use for that purpose. It means they went under rigorous testing and no risks to patients using them have been described by the manufacturer. There are no other risks. Where is the study run from? This study is run from 16 fertility centres across the UK. When is study starting and how long is it expected to run for? It is anticipated that recruitment will start in second half of 2013. The total study recruitment period is expected to last for a minimum of 21 months and then follow up will continue till the last pregnancy outcome is known. We plan to complete the study recruitment in 2016. Who is funding the study? Funding has been provided by National Institute for Health Research - Efficacy and Mechanisms Evaluation (NIHR-EME) grant, UK. Who is the main contact? Dr David Miller [email protected]

Critère d'inclusion

• Male-related fertility treatment

Liens

• ictrp
• isrctn