The PIP study
Research type
Research Study
Full title
The PIP Study- Pre-IVF Immune Profiling study. A feasibility study
IRAS ID
240968
Contact name
Ingrid Granne
Contact email
Sponsor organisation
Clinical Trials and Research Governance
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Many fertility clinics offer immune cell tests to women who have a history of subfertility or who have had a number of in vitro fertilisation (IVF) cycles in which embryos failed to implant (known as recurrent implantation failure (RIF)). The tests offered are usually to look at different immune cell types in the blood or in the lining of the womb (the endometrium.) These tests are very controversial as many scientists believe immune cells are unrelated to subfertility and failed implantation. The full study aims to answer these questions:
1. What are the normal blood and endometrial immune cell levels in women who undergo IVF because their partner has a very reduced sperm count and who go on to have a successful pregnancy after a first or second cycle? (These women will be considered to be a fertile control population.)
2. Are these cells different in women with sub fertility or who have RIF after IVF treatment?
3. Are there differences in these cells in women who become pregnant after IVF and those who don't?
4. Can we identify other differences in how immune cells work in women with sub fertility or RIF?
During this feasibility study we will recruit 250 women planning an IVF cycle at IVI clinics in Tamworth and Oxford and the Wolfson Fertility Centre, London. Women aged between 18 and 39 (inclusive) who consent will donate a sample of endometrium and a blood sample in the menstrual cycle before their treatment. The study will last for up to 3 years. The aim of the feasibility study is to assess whether we can recruit adequate numbers of patients to a fully powered study. If the feasibility study recruits successfully, the data acquired in the feasibility study will be further analysed with data acquired in the definitive study.REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0216
Date of REC Opinion
2 May 2018
REC opinion
Favourable Opinion