Trial record 14 of 79 for:    "Thrombophilia" OR "prothrombin thrombophilia"

The Effect of Heparin in Treatment IVF-ET Failure

This study has been completed.
Yazd Research & Clinical Center for Infertility
Information provided by:
Yazd Medical University Identifier:
First received: September 28, 2010
Last updated: October 1, 2010
Last verified: October 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 Intervention Phase
Drug: heparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: the Effect of Unfractionated Heparin in Treatment of IVF-ET Failure

Resource links provided by NLM:

Further study details as provided by Yazd Medical University:

Primary Outcome Measures:
  • chemical pregnancy rate [ Time Frame: until 12th gestational week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: until 12 gastational week ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   19 Years to 35 Years
Genders 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 .
  Contacts and Locations
Please refer to this study by its identifier: NCT01214772

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
Principal Investigator: Mehri Mashayekhy, infertility fellowship Yazd Research and Clinical Centre for Infertility
  More Information

No publications provided

Responsible Party: Dr Mehri Mashayekhy, Yazd Research and Clinical centre for infertility Identifier: NCT01214772     History of Changes
Other Study ID Numbers: 1378
Study First Received: September 28, 2010
Last Updated: October 1, 2010
Health Authority: Iran: Ethics Committee

Keywords provided by Yazd Medical University:

Additional relevant MeSH terms:
Hematologic Diseases
Calcium heparin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents processed this record on April 15, 2014