Low Molecular Weight Heparin in Recurrent Implantation Failure
Empirical Low Molecular Weight Heparin Administration in the Luteal Phase in Patients With Recurrent Implantation Failures: a Randomized Open Labeled Trial
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 9, 2008
CompletedFirst Posted
Study publicly available on registry
September 10, 2008
CompletedMarch 20, 2009
March 1, 2009
2.3 years
September 9, 2008
March 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ongoing pregnancy beyond the 20th gestational week rate
Secondary Outcomes (2)
Clinical pregnancy rate
Embryo implantation rate
Study Arms (2)
LMWH
EXPERIMENTALWomen 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
ACTIVE COMPARATORWomen in the control arm are administered routine luteal phase support without the addition of LMWH
Interventions
1 mg/kg/day subcutaneously in the luteal phase after IVF treatment
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assisted Reproduction Unit of the American Hospital of Istanbul
Istanbul, 34365, Turkey (Türkiye)
Related Publications (1)
Urman B, Ata B, Yakin K, Alatas C, Aksoy S, Mercan R, Balaban B. Luteal phase empirical low molecular weight heparin administration in patients with failed ICSI embryo transfer cycles: a randomized open-labeled pilot trial. Hum Reprod. 2009 Jul;24(7):1640-7. doi: 10.1093/humrep/dep086. Epub 2009 Apr 8.
PMID: 19357135DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cumhur B Urman, M.D.
American Hospital of Istanbul
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2008
First Posted
September 10, 2008
Study Start
January 1, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
March 20, 2009
Record last verified: 2009-03