Low Molecular Weight Heparin in Recurrent Implantation Failure - Full Text View

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

MedlinePlus related topics:

Infertility

ChemIDplus related topics:

Heparin Progesterone Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment

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

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
LMWH: Experimental Women in the LMWH arm are administered 0.1 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) 0.1 mg/kg/day subcutaneously in the luteal phase after IVF treatment
Control: Active Comparator 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

Exclusion Criteria:

Contacts and Locations

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

Study ID Numbers:	AH-05/11
First Received:	September 9, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00750451
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

Study placed in the following topic categories:

Genital Diseases, Female

Body Weight

Infertility

Progesterone

Heparin, Low-Molecular-Weight

Genital Diseases, Male

Heparin

Recurrence

Enoxaparin

Calcium heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents

Disease Attributes

Anticoagulants

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	V.K.V. American Hospital, Istanbul
Information provided by:	V.K.V. American Hospital, Istanbul
ClinicalTrials.gov Identifier:	NCT00750451