Topic: Reproductive Health and Childbirth
Conditions
Interventions
Dietary intervention, The intervention diet consists of a daily supplemented drink high in Vitamin D (10 micrograms) and the omega 3 fatty acids EPA and DHA (2 g daily) together with standard doses of
Sponsors
Southampton University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Standard indication for IVF/ICSI treatment 2. Female BMI between 20 and 32kg/m2 3. Non-smoker for previous 6 months 4. Good understanding of written and spoken English
Exclusion criteria
Exclusion criteria: 1. More than two previous unsuccessful IVF cycles 2. Female age >41 3. Anti-mullerian hormone (AMH) less than 7pmol/l or antral follicle count (AFC) less than 10 4. Previously diagnosed diabetes 5. Previous diagnosis of HIV, Hepatitis B or C 6. Any medical contraindication to IVF/ICSI treatment 7. Any medical contraindication to a specific dietary intervention 8. Taking any prescribed medication or herbal remedies apart from simple painkillers 9. Eating oily fish (as defined by the Food Standards Agency) more than once per week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Embryo development from zygote to blastocyst stage will be monitored using a validated time-lapse incubator and analysed according to the time of embryo cleavage from two to three cells (CC2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Other embryo development markers will be analysed including CC3 (the duration of the third cell cycle), S2 (the synchrony in division from two to four cells), T5 (the time of division to 5 cells) and the time of appearance and disappearance of the pronuclei. These markers have all been demonstrated to be related to embryo quality and hence pregnancy rates. Other secondary outcomes that will be examined include the changes in nutritional status of blood, uterine fluid and follicular fluid prior to and following the intervention in the control and placebo group. The immune cell populations in the endometrium will also be analysed as previous studies have shown that these may be modulated by local inflammatory mediators, including eicosanoids, the expression of which is dependent on fatty acid substrates. Changes in semen quality and the nutritional content of the sperm and seminal fluid will be assessed and compared between the two groups. Fertility markers such as number of cleavage stage embryos; number of embryo of sufficient quality for cryopreservation; implantation rates and clinical pregnancy rates will be recorded. In those participants with ongoing pregnancies, antenatal markers will be measured at 7, 12 and 20 weeks by ultrasound scan including fetal crown rump length, head circumference, brain volume, abdominal circumference, femur length, cross sectional distal metaphyseal volume and placental volume. Perinatal markers (birthweight and length and placental dimensions and weight) will be documented at birth and, in participants who consent, a neonatal DXA to assess bone density will be performed. | — |
Countries
United Kingdom
Outcome results
None listed