Low Molecular Weight Heparin in Recurrent Implantation Failure

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750451
• Other study ID #: AH-05/11
• Status: Completed
• Phase: N/A
• First received: September 9, 2008
• Last updated: March 19, 2009
• Start date: January 2006
• Est. completion date: May 2008

Study information

• Verified date: March 2009
• Source: V.K.V. American Hospital, Istanbul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fertilization in Vitro
• Infertility
• Recurrent Implantation Failure

Intervention

Drug:
• low molecular weight heparin (enoxaparine sodium)
1 mg/kg/day subcutaneously in the luteal phase after IVF treatment
• crinone 8% gel
routine luteal phase support with progesterone gel

Locations

Country	Name	City	State
Turkey	Assisted Reproduction Unit of the American Hospital of Istanbul	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
V.K.V. American Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy beyond the 20th gestational week rate
Secondary	Clinical pregnancy rate
Secondary	Embryo implantation rate