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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 4 December 2018
Main ID:  ISRCTN50956936
Date of registration: 10/02/2014
Prospective Registration: No
Primary sponsor: Southampton University Hospitals NHS Trust (UK)
Public title: PREPARE (PREconcePtional diet in Assisted Reproductive tEchnology): Preconceptional diet and embryo quality
Scientific title: A randomised controlled trial of a preconceptional dietary intervention in women undergoing IVF treatment
Date of first enrolment: 01/02/2014
Target sample size: 220
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN50956936
Study type:  Interventional
Study design:  Single-centre double-blinded randomised controlled trial (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name: Alex  Kermack
Address:  University of Southampton Obstetrics and Gynaecology (MP 815) Room F89, Level F Princess Anne Hospital Coxford Road SO16 5YA Southampton United Kingdom
Telephone: -
Email: Alexandra.Kermack@uhs.nhs.uk
Affiliation: 
Name:  
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Topic: Reproductive Health and Childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth
Pregnancy and Childbirth
Intervention(s)

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 Vitamin C and Folic acid. They will also be asked to use olive oil for cooking and olive oil based spreads.

The control diet consists of a daily supplemented drink (Folic acid and Vitamin C only) with sunflower oil and sunflower oil based spreads.
Primary Outcome(s)
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 Outcome(s)

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.
Secondary ID(s)
15896
Source(s) of Monetary Support
The main funding for the study comes from the NIHR Southampton Biomedical Research Centre (UK) - This is Project 1b of Area 1 of the BRC's research programme., Some funding will come from Complete Fertility Centre., Smartfish will provide materials (drinks) at no charge, and Fertilitech will loan us the embryo incubator with time lapse analysis facility.
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
NRES Committee South Central - Oxford A,15/11/2013, ref.:13/SC/0544
Results
Results available: Yes
Date Posted:
Date Completed: 31/01/2016
URL:
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