Endometrial Flushing of LMW Heparin Improves Decidualisation

• Research type

  Research Study

• Full title

  Endometrial Flushing of Low Molecular Weight Heparin Improves Decidualisation- a prospective randomised control pilot study

• IRAS ID

  112835

• Contact name

  Siobhan Quenby

• Eudract number

  2012-003682-18

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Every year in England and Wales there are 700,000 births and thus hundreds of thousands of delighted parents. However, many couples are not so fortunate; in the same period of time: 15% of couples experience sub-fertility; 25% (500,000) of conceptions fail to implant; 15% (300,000) of pregnancies end in early miscarriage; 2% of couples suffer recurrent miscarriages (three or more losses. We have shown that failure of the lining of the womb (endometrium) to prepare adequately for pregnancy a process known as decidualisation is an underlying factor in these clinical problems. During decidualisation, the endometrial lining becomes transformed into a secretory lining in preparation for accepting the embryo. Decidualisation is a characteristic of the endometrium of the pregnant uterus. Decidualisation is a process that occurs in early pregnancy. It is an adaption of the uterus to enable implantation of the embryo. The blood thinning agent, Heparin, has been used in an attempt to improve reproductive success. However, heparin has always been given by daily sub-cutaneous injections causing bruising, pain and occasionally bleeding. These injections are given for weeks. Heparin also has the ability to increase activity of growth factors in the endometrium thereby improving decidualisation and increase successful implantation of the pregnancy. We would like administer Heparin as a single dose bfluhing it directly into the womb prior to pregnancy, during the window of implantation (5-7 days after ovulation). We wish to study whether this new method of administration enhances decidualisation and minimises the adverse effects of heparin. Women in the study will be randomly allocated to either in the intervention group (Heparin) or Control group (normal saline). The endometrium will then be sampled and its decidualisation studied. Adverse effects on the women will also be recorded.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  12/WM/0347

• Date of REC Opinion

  5 Nov 2012

• REC opinion

  Further Information Favourable Opinion