Heparin improves the lining of the womb's preparation for pregnancy
- Conditions
- Previous at least one unsuccessful IVF treatment, Recurrent MiscarriagesPregnancy and ChildbirthSpontaneous abortion
- Registration Number
- ISRCTN78466363
- Lead Sponsor
- niversity of Warwick (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 40
1. Women attending the Centre for Reproductive Medicine, University Hospitals of Coventry and Warwickshire NHS Trust, Coventry who had previous one unsuccessful IVF treatment (defined as failure to achieve live birth after transfer of two good quality embryos)
2. Women with recurrent miscarriages (defined as 3 or more unexplained miscarriages)
3. Women 18 years of age or older but younger than 45 years old
4. Able and willing to give informed consent
1. Women who had unprotected sexual intercourse during the month when endometrial flushing is planned
2. Women having a vaginal infection, these women will be eligible for inclusion once treatment of the infection has been completed
3. Pregnancy
4. Breast feeding
5. Women with weight of < 45 kg (due to higher risk of bleeding)
6. Women with bleeding disorders
7. Women with severe hypertension
8. Women with Known Renal or Liver Diseases
9. Women who had recent stroke
10. Women taking Warfarin for any medical condition
11. Women taking systemic steroids, systemic salicylates, acetylsalicylic acid, NSAIDS including Ketorolac, dextran and clopidogrel or any immunosuppressant medications
12. Women with Diabetes Mellitus (due to potential risk of hyperkalaemia)
13. Women with hypersensitivity to Heparin, Pork, Beef or other Animal products
14. Women with Peptic Ulcers
15. Women undergoing Tubal Patency testing, Hysteroscopy or Laparoscopy at the time when endometrial flushing is planned
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of effective decidualisation will include the density of uterine natural killer cell by immunohistochemistry
- Secondary Outcome Measures
Name Time Method 1. To assess the effect of locally administered heparin on other markers of decidualisation including endometrial stromal cell culture, genome wide expression profile, induction of other decidualisation protein markers including prolactin, Prokinectin, IGFBPs (insulin Like Growth Factor Binding Proteins), HBEGF (Heparin Binding Epidermal Growth Factor)<br>2. To identify any potential side effects of local endometrial administration of heparin<br>3. To assess patient acceptability of this method of administration