Extract

Background and study aims The Southampton Women's Survey showed that the diet of both men and women can affect their fertility, the health of the pregnancy and the long term wellbeing of the children. Studies suggest that a diet rich in Vitamin D and omega-3 fats might improve the outcome from in vitro fertilisation (IVF) but this idea has not been tested. In this context it is known that some fats are essential for the cells that are required by the lining of the womb to allow it to receive a developing pregnancy. We think that a short period of improved diet in couples wishing to embark on IVF after a prolonged period of subfertility may make a difference to the success of the IVF. Therefore we are conducting this study to test our idea. Who can participate? Couples about to undergo IVF will be recruited from the Complete Fertility Centre situated in Princess Anne Hospital, Southampton. What does the study involve? The couples will be randomly allocated to the test diet or to the control diet. The test diet will be a daily fruit-based drink high in Vitamin D and omega -3 fats together with standard doses of Vitamin C and folic acid plus olive oil for cooking and olive oil-based spreads. The control diet will be the daily fruit-based drink without added Vitamin D or omega-3 fats but including the Vitamin C and folic acid plus sunflower oil for cooking and sunflower oil-based spreads. The results will be analysed to determine whether the intervention diet improves the quality and number of embryos obtained from the IVF cycle. Differences in the nutrient content of the fluid from the womb and ovaries and of the woman's blood between the two groups will also be examined, as will any change in the man's semen quality. Following IVF, the baby's growth will be measured at 7, 12 and 20 weeks of pregnancy and at birth the baby's birth weight and length will be recorded. In the first few weeks of life the baby's bone density will be measured. What are the possible risks and benefits of taking part? There are a number of benefits of taking part in the study. The couple will be provided with a food hamper that may improve their health. An endometrial scratch (taking a sample from the lining of the womb) will also be carried out; this is thought to increase the chances of success during IVF. Finally, an embryoscope will be used to culture and closely monitor the growing embryos; if the embryo is transferred then the couple will be given a copy of this film. There are no immediate direct risks of participating in the study. Additional samples of fluid and tissue will be taken, the risks of which are negligible. Where is the study run from? The study will be conducted from the Complete Fertility Centre, Princess Anne Hospital and the University of Southampton, UK. When is the study starting and how long is it expected to run for? Study recruitment will start in February 2014 and continue for about 18 months. Who is funding the study? The funding has been received from the NIHR Southampton Biomedical Research Centre in Nutrition and Complete Fertility Centre at the University Hospital Southampton NHS Foundation Trust, UK. Who is the main contact? Dr Alexandra Kermack [email protected]

Inclusion criteria

• Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth

Links

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• isrctn