Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments

Study Overview
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Brief Summary
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In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian hyperstimulation.

Detailed Description
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Low-dose acetylsalicylic acid irreversibly inhibits the cyclo-oxygenase enzyme in platelets, thus preventing the synthesis of thromboxane, which causes vasoconstriction and platelet aggregation. By this mechanism low-dose aspirin may enhance ovarian and uterine blood flow and tissue perfusion and thus improve ovarian responsiveness for gonadotrophins and endometrial receptivity for implantation. Randomized controlled studies and meta-analyses on the low-dose aspirin therapy to improve IVF/ICSI outcome or uterine hemodynamics have revealed conflicting results.

Official Title
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The Significance of Low-Dose Aspirin on Ovarian Responsiveness, Uterine Hemodynamics and Pregnancy Outcome in in Vitro Fertilization and in Intracytoplasmic Sperm Injection: A Randomized, Placebo-Controlled Double-Blind Study

Conditions
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Pregnancy, Miscarriage Less Than 12 Gestational Weeks, Extrauterine Pregnancy, Preeclampsia, Intrauterine Fetal Growth Restriction

Intervention / Treatment
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* Drug: Acetylsalicylic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age < 40 years < 4 previous ovarian stimulations Exclusion Criteria: allergy for acetylsalicylic acid

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Acetylsalicylic acid 100 mg daily perorally | Drug: Acetylsalicylic acid<br>* Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection<br>* Other names: Low-dose aspirin;|
| Placebo Comparator: 2<br>Placebo daily perorally | Drug: Placebo<br>* Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | Five weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine artery and spiral artery pulsatility index values |  | On the day of embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assisted reproduction, Ovarian response, Uteroplacental hemodynamics, Doppler ultrasonography, Implantation rate, Pregnancy rate, Live birth rate