Low Molecular Weight Heparin in Recurrent Implantation Failure

V.K.V. American Hospital, Istanbul

Status: Completed

Conditions: Fertilization in Vitro; Infertility; Recurrent Implantation Failure

Treatments: Drug: low molecular weight heparin (enoxaparine sodium); Drug: crinone 8% gel

Study type: Interventional

Funder types: Other

Identifiers

NCT00750451

AH-05/11

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

LMWH

Experimental group

Description:

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

Treatment:

Drug: low molecular weight heparin (enoxaparine sodium)

Control

Active Comparator group

Description:

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

Treatment:

Drug: crinone 8% gel