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Low Molecular Weight Heparin in Recurrent Implantation 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: NCT00750451
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : March 20, 2009
Information provided by:
V.K.V. American Hospital, Istanbul

Brief Summary:
Recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts with in vitro fertilization treatment. The reason is usually obscure. Many empirical treatments have been offered without substantial evaluation. Heparin is thought to play a role in the embryo implantation process beyond its anticoagulation effects. The proposed study aims to assess the effectiveness and safety of empirical administration of low molecular weight heparin in patients undergoing a new IVF treatment cycle after multiple failed attempts.

Condition or disease Intervention/treatment
Infertility Fertilization in Vitro Recurrent Implantation Failure Drug: low molecular weight heparin (enoxaparine sodium) Drug: crinone 8% gel

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Empirical Low Molecular Weight Heparin Administration in the Luteal Phase in Patients With Recurrent Implantation Failures: a Randomized Open Labeled Trial
Study Start Date : January 2006
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: LMWH
Women in the LMWH arm are administered 1 mg/kg/day subcutaneously low molecular weight heparin after oocyte collection in addition to routine luteal phase support with vaginal progesterone
Drug: low molecular weight heparin (enoxaparine sodium)
1 mg/kg/day subcutaneously in the luteal phase after IVF treatment
Active Comparator: Control
Women in the control arm are administered routine luteal phase support without the addition of LMWH
Drug: crinone 8% gel
routine luteal phase support with progesterone gel

Primary Outcome Measures :
  1. Ongoing pregnancy beyond the 20th gestational week rate

Secondary Outcome Measures :
  1. Clinical pregnancy rate
  2. Embryo implantation rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • History of at least two previously failed fresh embryo transfer cycles
  • All previously failed cycles to be performed in the American Hospital of Istanbul
  • Female age ≤ 38 years
  • Fresh ejaculate sperms to be used for ICSI
  • No hormonal, coagulation, or immunological disorders detected
  • Normal uterine cavity, as assessed by diagnostic office hysteroscopy or saline infusion sonography
  • Normal female and male peripheral karyotype

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): NCT00750451

Assisted Reproduction Unit of the American Hospital of Istanbul
Istanbul, Turkey, 34365
Sponsors and Collaborators
V.K.V. American Hospital, Istanbul
Study Director: Cumhur B Urman, M.D. American Hospital of Istanbul

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00750451     History of Changes
Other Study ID Numbers: AH-05/11
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: March 20, 2009
Last Verified: March 2009

Keywords provided by V.K.V. American Hospital, Istanbul:
fertilization in vitro
assisted reproduction
recurrent implantation failure
low molecular weight heparin
luteal phase

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Calcium heparin
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action