Effects of Aspirin and Low Molecular Weight Heparin in IVF Outcome.

Study Overview
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Brief Summary
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The purpose of the study is to determine whether low-dose aspirin and low molecular weight heparin improve the implantation and pregnancy rates in patients with repeated implantation failures in IVF cycle.

Detailed Description
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The investigators hypothesize that cotreatment of low dose aspirin & low molecular weight heparin may improve implantation & clinical pregnancy rates.

Official Title
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Effects of Low Dose Aspirin and Low Molecular Weight Heparin Cotreatment, Alone and/or in Combination on Implantation and Clinical Pregnancy Rates in Repeated Implantation Failures in IVF Cycle.

Conditions
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To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come

Intervention / Treatment
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* Drug: Low molecular weight heparin
* Drug: Low dose aspirin
* Drug: Heparin & aspirin
* Other: NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 19 to 35 years; Basal follicle-stimulating hormone (FSH) levels of ≤8 IU/l Body mass index (BMI) between 19 kg/m2 and 25 kg/m2 Presence of both ovaries; ≥2 previous IVF failures Good quality embryos for transfer Endometrial thickness between 10 mm and 14 mm Exclusion Criteria: Polycystic ovary syndrome Endometriosis

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Molecular Weight Heparin<br>Low molecular weight heparin, 2500 milli-International unit/day, subcutaneously | Drug: Low molecular weight heparin<br>* 2500 mIU/day, subcutaneously<br>* Other names: LMWH;|
| Active Comparator: Low dose aspirin<br>Low dose aspirin, 75mg/day, orally | Drug: Low dose aspirin<br>* 75 mg/day, orally<br>* Other names: Ecoaspirin;|
| Active Comparator: Heparin & Aspirin<br>Heparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally) | Drug: Heparin & aspirin<br>* Aspirin (70 mg/day, orally) & heparin (40 mg/day, subcutaneously)<br>* Other names: LMWH & Ecoaspirin;|
| Placebo Comparator: Sodium chloride (NaCl)<br>Equivalent volume of NaCl 0.9%, subcutaneously | Other: NaCl<br>* Equivalent volume of NaCl 0.9%, subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological pregnancy test |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal heart/Gestational sac |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF failure, implantation rate, heparin & aspirin