The Effect of Heparin in Treatment IVF-ET Failure
|ClinicalTrials.gov Identifier: NCT01214772|
Recruitment Status : Completed
First Posted : October 5, 2010
Last Update Posted : October 5, 2010
Embryo transfer failure is defined as ≥3 IVF-embryo transfer failures without pregnancy . In spite of transfer of 3 good quality embryos , just 20-30% of women undergoing IVF will achieve ongoing pregnancy . There are multiple factors that influence IVF-failure.
Autoantibodies may be one of the possible causes of IVF-failure , especially in unexplained and mechanical infertility .
In some studies , antiphospholipid antibody is considered as causative factor on implantation and embryo failure. However some investigators showed that combination therapy with heparin/aspirin in women with positive antiphospholipid antibody is not effective in improving of IVF-outcome . In prospective studies were not confirmed association between antiphospholipid antibody abnormalities and IVF-failure.
Recently has been relationship between thrombophilia and IVF and implantation failure.
The effect of unfractionated heparin in assisted reproductive technology (ART) cycles is prevention of thrombosis in implantation site . Although its effect is not restricted to anticoagulation and also can modulate apposition , adhesion , and penetration of embryo . Other advantages are decreasing thrombophilic risk in COH ( controlled ovarian hyperstimulation) cycles with administration of gonadotrophins . So heparin make better pregnancy rate in repeated IVF-ET failures.
There are few studies in regard to heparin effects on IVF cycles outcome . The purpose of this study is evaluation of unfractionated heparin effects on improvement of ART outcome .
This study was a prospective randomized controlled trial to assess whether administration of heparin would increased pregnancy rates in women with repeated ET-IVF failures.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Thrombophilia||Drug: heparin||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||the Effect of Unfractionated Heparin in Treatment of IVF-ET Failure|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||June 2010|
Experimental: heparin,pregnancy,IVF failure
Women in the heparin arm are administered 5000 IU twice a day on the day of embryo transfer
5000 IU subcutaneously in the day of embryo transfer until 6 week after delivery
- chemical pregnancy rate [ Time Frame: until 12th gestational week ]
- clinical pregnancy rate [ Time Frame: until 12 gastational week ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214772
|Iran, Islamic Republic of|
|Yazd Research and Clinical Centre for Infertility|
|Yazd, Iran, Islamic Republic of, 8916877391|
|Principal Investigator:||Mehri Mashayekhy, infertility fellowship||Yazd Research and Clinical Centre for Infertility|