Low Molecular Weight Heparin in Recurrent Implantation Failure

March 19, 2009 updated by: V.K.V. American Hospital, Istanbul

Empirical Low Molecular Weight Heparin Administration in the Luteal Phase in Patients With Recurrent Implantation Failures: a Randomized Open Labeled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34365
        • Assisted Reproduction Unit of the American Hospital of Istanbul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ongoing pregnancy beyond the 20th gestational week rate

Secondary Outcome Measures

Outcome Measure
Clinical pregnancy rate
Embryo implantation rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

V.K.V. American Hospital, Istanbul

Investigators

  • Study Director: Cumhur B Urman, M.D., American Hospital of Istanbul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 9, 2008

First Submitted That Met QC Criteria

September 9, 2008

First Posted (Estimate)

September 10, 2008

Study Record Updates

Last Update Posted (Estimate)

March 20, 2009

Last Update Submitted That Met QC Criteria

March 19, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AH-05/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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