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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. Identifier: NCT01214772
Recruitment Status : Completed
First Posted : October 5, 2010
Last Update Posted : October 5, 2010
Yazd Research & Clinical Center for Infertility
Information provided by:
Yazd Medical University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: heparin,pregnancy,IVF failure
Women in the heparin arm are administered 5000 IU twice a day on the day of embryo transfer
Drug: heparin
5000 IU subcutaneously in the day of embryo transfer until 6 week after delivery

Primary Outcome Measures :
  1. chemical pregnancy rate [ Time Frame: until 12th gestational week ]

Secondary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: until 12 gastational week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who were 19-35 years old
  • basal FSH < 10 IU/l
  • body mass index ( BMI ) < 29 Kg/m²
  • presence of both ovaries
  • three or more pervious IVF-ET failures
  • Top-quality embryos for transfer .

Exclusion Criteria:

  • Women with polycystic ovary syndrome ( PCOS)
  • endometriosis
  • hydrosalpinx
  • chronic systemic disease( liver, renal , thyroid and thrombocytopenia ) ●Abnormal uterine cavity
  • sever male factor ( azospermia )
  • Patients who had contraindication for unfractionated heparin therapy .

Information from the National Library of Medicine

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 identifier (NCT number): NCT01214772

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Iran, Islamic Republic of
Yazd Research and Clinical Centre for Infertility
Yazd, Iran, Islamic Republic of, 8916877391
Sponsors and Collaborators
Yazd Medical University
Yazd Research & Clinical Center for Infertility
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Principal Investigator: Mehri Mashayekhy, infertility fellowship Yazd Research and Clinical Centre for Infertility
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Responsible Party: Dr Mehri Mashayekhy, Yazd Research and Clinical centre for infertility Identifier: NCT01214772    
Other Study ID Numbers: 1378
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: October 5, 2010
Last Verified: October 2010
Keywords provided by Yazd Medical University:
Additional relevant MeSH terms:
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Hematologic Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action