Low Molecular Weight Heparin in Recurrent Implantation Failure

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility, Fertilization in Vitro, Recurrent Implantation Failure

Intervention / Treatment
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* Drug: low molecular weight heparin (enoxaparine sodium)
* Drug: crinone 8% gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMWH<br>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 | Drug: low molecular weight heparin (enoxaparine sodium)<br>* 1 mg/kg/day subcutaneously in the luteal phase after IVF treatment<br>|
| Active Comparator: Control<br>Women in the control arm are administered routine luteal phase support without the addition of LMWH | Drug: crinone 8% gel<br>* routine luteal phase support with progesterone gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy beyond the 20th gestational week rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  |  | 
| Embryo implantation rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fertilization in vitro, assisted reproduction, recurrent implantation failure, low molecular weight heparin, heparin, luteal phase