SIMPLANT
Research type
Research Study
Full title
Does the DPP4 Inhibitor (Sitagliptin) Increase Endometrial Mesenchymal Stem Cells in Women with Recurrent Miscarriage?
IRAS ID
196058
Contact name
Siobhan Quenby
Contact email
Sponsor organisation
University Hospitals Coventry and Warwickshire NHS Trust
Eudract number
2016-001120-54
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Miscarriage is defined as the loss of pregnancy before 24 weeks of pregnancy and is the most common complication of pregnancy. As many as 15-25% of pregnancies end in miscarriage, and 25-50% of women experience at least one miscarriage in their reproductive life. It is a distressing condition that is very challenging to treat.
Despite many randomised controlled trials the only effective treatment to prevent miscarriage is heparin and aspirin for those women with antiphospholipid syndrome (APLS). APLS occurs in only 15% women with recurrent miscarriage so, there is no effective treatment for 85% of recurrent miscarriage patients.
Currently, all treatment given to patients to prevent recurrent miscarriage starts once the patient is pregnant. We wish to design a PRE-conception treatment for those with recurrent miscarriage which could help such patients achieve a successful pregnancy.
This study is based on new evidence that has shown that there is a strong association between recurrent miscarriage and a deficiency in stem cells at the endometrium (lining of the womb). The SIMPLANT study aims to look further into this key finding and see if we can help to increase stem cells at endometrium in the hope that this will reduce subsequent miscarriages.
We will be comparing the effect of taking a medication called Sitagliptin, which has been shown in animal studies to increase the number of stem cells in other areas of the body in response to injury, with a placebo (dummy tablet).
We will compare the number of stem cells present in the endometrium before and after 3 months of Sitagliptin or placebo, to see whether the stem cell count has increased and the lining of the womb has become more favourable for successful implantation.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
16/SC/0229
Date of REC Opinion
14 Jun 2016
REC opinion
Further Information Favourable Opinion