Back to resultsLow Molecular Weight Heparin in Recurrent Implantation Failure
Primary Purpose
Infertility, Fertilization in Vitro, Recurrent Implantation Failure
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
low molecular weight heparin (enoxaparine sodium)
crinone 8% gel
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring fertilization in vitro, assisted reproduction, recurrent implantation failure, low molecular weight heparin, heparin, luteal phase
Eligibility 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
Sites / Locations
- Assisted Reproduction Unit of the American Hospital of Istanbul
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LMWH
Control
Arm 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
Women in the control arm are administered routine luteal phase support without the addition of LMWH
Outcomes
Primary Outcome Measures
Ongoing pregnancy beyond the 20th gestational week rate
Secondary Outcome Measures
Clinical pregnancy rate
Embryo implantation rate
Full Information
NCT ID
NCT00750451
First Posted
September 9, 2008
Last Updated
March 19, 2009
Sponsor
V.K.V. American Hospital, Istanbul
1. Study Identification
Unique Protocol Identification Number
NCT00750451
Brief Title
Low Molecular Weight Heparin in Recurrent Implantation Failure
Official Title
Empirical Low Molecular Weight Heparin Administration in the Luteal Phase in Patients With Recurrent Implantation Failures: a Randomized Open Labeled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
V.K.V. American Hospital, Istanbul
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Fertilization in Vitro, Recurrent Implantation Failure
Keywords
fertilization in vitro, assisted reproduction, recurrent implantation failure, low molecular weight heparin, heparin, luteal phase
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
LMWH
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Women in the control arm are administered routine luteal phase support without the addition of LMWH
Intervention Type
Drug
Intervention Name(s)
low molecular weight heparin (enoxaparine sodium)
Intervention Description
1 mg/kg/day subcutaneously in the luteal phase after IVF treatment
Intervention Type
Drug
Intervention Name(s)
crinone 8% gel
Intervention Description
routine luteal phase support with progesterone gel
Primary Outcome Measure Information:
Title
Ongoing pregnancy beyond the 20th gestational week rate
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Title
Embryo implantation rate
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cumhur B Urman, M.D.
Organizational Affiliation
American Hospital of Istanbul
Official's Role
Study Director
Facility Information:
Facility Name
Assisted Reproduction Unit of the American Hospital of Istanbul
City
Istanbul
ZIP/Postal Code
34365
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
19357135
Citation
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.
Results Reference
derived
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Low Molecular Weight Heparin in Recurrent Implantation Failure
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