Low Molecular Weight Heparin in Recurrent Implantation Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility Fertilization in Vitro Recurrent Implantation Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

low molecular weight heparin (enoxaparine sodium)

Intervention Type DRUG

1 mg/kg/day subcutaneously in the luteal phase after IVF treatment

Control

Women in the control arm are administered routine luteal phase support without the addition of LMWH

Group Type ACTIVE_COMPARATOR

crinone 8% gel

Intervention Type DRUG

routine luteal phase support with progesterone gel

Interventions

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low molecular weight heparin (enoxaparine sodium)

1 mg/kg/day subcutaneously in the luteal phase after IVF treatment

Intervention Type DRUG

crinone 8% gel

routine luteal phase support with progesterone gel

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No