The Effect of Heparin in Treatment IVF-ET Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|