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OpenTrials
Completed

NCT Number: NCT00750451

Low Molecular Weight Heparin in Recurrent Implantation Failure

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.

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Key information

Conditions

Infertility Fertilization in Vitro Genital Diseases Recurrent Implantation Failure Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assisted Reproduction Unit of the American Hospital of Istanbul

Istanbul, 34365, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low molecular weight heparin (enoxaparine sodium)

Drug

1 mg/kg/day subcutaneously in the luteal phase after IVF treatment

Crinone 8% gel

Drug

routine luteal phase support with progesterone gel

Primary outcomes

  1. Ongoing pregnancy beyond the 20th gestational week rate

Secondary outcomes

  1. Clinical pregnancy rate

  2. Embryo implantation rate

Sponsors and collaborators

Lead sponsor

V.K.V. American Hospital, Istanbul

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 10, 2008
Registry last updated
Mar 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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