The Effect of Heparin in Treatment IVF-ET Failure

This study has been completed.
Sponsor:
Collaborator:
Yazd Research & Clinical Center for Infertility
Information provided by:
Yazd Medical University
ClinicalTrials.gov Identifier:
NCT01214772
First received: September 28, 2010
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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
Pregnancy
Thrombophilia
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

  Eligibility

Ages Eligible for Study:   19 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214772

Locations
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
Investigators
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
ClinicalTrials.gov 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:
pregnancy
heparin
fertilization

Additional relevant MeSH terms:
Thrombophilia
Hematologic Diseases
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 29, 2014