Low Molecular Weight Heparin in Recurrent Implantation Failure

Sponsor

V.K.V. American Hospital, Istanbul (Other)

Overall Status

Completed

CT.gov ID

NCT00750451

Collaborator

(none)

Location

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility Fertilization in Vitro Recurrent Implantation Failure	Drug: low molecular weight heparin (enoxaparine sodium) Drug: crinone 8% gel	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Ongoing pregnancy beyond the 20th gestational week rate []

Secondary Outcome Measures

Clinical pregnancy rate []
Embryo implantation rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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