Extrait

Background and study aims There is a suggestion that seminal plasma (seminal fluid with no sperm) may play a role in the egg implanting into the womb. In patients undergoing fertility treatment to help them have a baby, such as in-vitro fertilization (IVF) or intra-cytoplasmatic injection (ICSI), seminal fluid does not come into contact with the womb, as embryos are transferred without seminal plasma and patients usually abstain (or advised to abstain) from sexual intercourse for several days both before and after egg retrieval. Seminal fluid contains several proteins that interact with cells in the endometrium (lining of the womb) to induce a cascade which activates maternal immune activity to accept the 'invading' embryo. Animal and human studies have suggested that when participants are inserted with seminal plasma during fertility treatment they have higher levels of conception in comparison to their controls. The aim of this study is to investigate whether seminal plasma injected into the uterine cavity during fertility treatment improves clinical pregnancy rates. Who can participate? Patients aged between 23 and 39 years old undergoing IVF at the Homerton Fertility Centre who are undergoing their first or second cycle of IVF using their partner’s fresh sperm for their IVF cycle and not sperm that has been frozen or that comes from a donor. What does the study involve? Participants are randomly allocated to one of two groups on the day that eggs are collected from the woman to fertilise with her partner's sperm to create an embryo in the lab. As usual procedure the male partner’s sperm will be separated from the seminal fluid in the laboratory. Usually the remaining fluid will be discarded by the embryologist. However, for this researches purpose they will not be discarded. After egg collection, if the patient is in the first group they receive 0.5 ml of their partner's seminal fluid by injection into their womb. Those in the other group receive a 0.5 ml injection of placebo (dummy) fluid. This procedure takes less than 2-3 minutes. Treatment before and after the day of egg collection is completely routine. One month after the study, pregnancy results are recorded. What are the possible benefits and risks of participating? There are no direct benefits or risks involved with participating in this study. Where is the study run from? Homerton Fertility Centre (UK) When is study starting and how long is it expected to run for? July 2013 and October 2015 Who is funding the study? Homerton Fertility Centre (UK) Who is the main contact? Dr Giselle Crawford [email protected]

Critère d'inclusion

• Infertility requiring in vitro fertilisation for its management

Liens

• isrctn