Condition category
Pregnancy and Childbirth
Date applied
10/02/2014
Date assigned
10/02/2014
Last edited
07/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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
Alexandra.Kermack@uhs.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alex Kermack

ORCID ID

Contact details

University of Southampton
Obstetrics and Gynaecology (MP 815)
Room F89
Level F
Princess Anne Hospital
Coxford Road
Southampton
SO16 5YA
United Kingdom
-
Alexandra.Kermack@uhs.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15896

Study information

Scientific title

A randomised controlled trial of a preconceptional dietary intervention in women undergoing IVF treatment

Acronym

PREPARE

Study hypothesis

That a specific dietary intervention delivering healthy nutrients started 6 weeks prior to IVF will improve embryo quality and development.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15896

Ethics approval

NRES Committee South Central - Oxford A,15/11/2013, ref.:13/SC/0544

Study design

Single-centre double-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Intervention

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.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/02/2014

Overall trial end date

31/01/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 220

Participant 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

Recruitment start date

01/02/2014

Recruitment end date

01/08/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
Southampton
SO16 5YA
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

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.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Some funding will come from Complete Fertility Centre.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Smartfish will provide materials (drinks) at no charge, and Fertilitech will loan us the embryo incubator with time lapse analysis facility.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25407227

Publication citations

Additional files

Editorial Notes