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Low Molecular Weight Heparin in Recurrent Implantation Failure

This study has been completed.
Sponsor:
Information provided by:
V.K.V. American Hospital, Istanbul
ClinicalTrials.gov Identifier:
NCT00750451
First received: September 9, 2008
Last updated: March 19, 2009
Last verified: March 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by V.K.V. American Hospital, Istanbul:

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

Secondary Outcome Measures:
  • Clinical pregnancy rate
  • Embryo implantation rate

Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00750451

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

No publications provided by V.K.V. American Hospital, Istanbul

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00750451     History of Changes
Other Study ID Numbers: AH-05/11
Study First Received: September 9, 2008
Last Updated: March 19, 2009
Health Authority: Turkey: Ministry of Health

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Calcium heparin
Dalteparin
Heparin
Heparin, Low-Molecular-Weight
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014