Low Molecular Weight Heparin in Recurrent Implantation Failure

Not Applicable

Completed

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

• Registration Number: NCT00750451
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-09-09
• Study First Submitted QC: 2008-09-09
• Study First Posted: 2008-09-10
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-19
• Last Update Posted: 2009-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMWH	low molecular weight heparin (enoxaparine sodium)	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
Control	crinone 8% gel	Women in the control arm are administered routine luteal phase support without the addition of LMWH

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy beyond the 20th gestational week rate

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate
Embryo implantation rate

Trial Locations

Locations (1)

Assisted Reproduction Unit of the American Hospital of Istanbul; 🇹🇷 Istanbul, Turkey