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Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology

This study seeks to validate the hypothesis that nulliparous pregnant women after Assisted Reproductive Technology (ART) are at high risk of preeclampsia and perinatal complications and represent a subgroup for which aspirin prophylaxis during pregnancy may be effective in the prevention of preterm preeclampsia and other perinatal adverse outcomes.

ClinicalTrials.gov IDNCT05625724

PhasePHASE3

Enrollment1164

SponsorUniversity Hospital, Toulouse

Age18 Years and older

SexFEMALE

I'm interested View official listing

Conditions studied

ART, Pre-Eclampsia

About this study

Interventions

Drug: Aspirin — Experimental drug administrated orally
Drug: Placebo — Treatment for the control group

Primary outcomes

Effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo in the prevention of preterm (<37 weeks of gestation) preeclampsia (Up to 9 months)

Eligibility information

Inclusion Criteria: * Nulliparous women aged 18 years or more * Pregnancy following ART, including in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), oocyte donation or intrauterine insemination with sperm donor * Singleton pregnancy * Evolutive pregnancy between 9 and 14 weeks of gestation * Women affiliated to a French Social Security Insurance or equivalent social protection * Written informed consent Exclusion Criteria: * Major fetal abnormality * Regular treatment with aspirin (including antiphospholipid syndrome) * Aspirin contraindications (allergy, von Willebrand disease, peptic ulceration, hemophilia) * Women protected by law. * Women included in another interventional study.

Study locations

CHU Angers, Angers, France
CHU Bordeaux, Bordeaux, France
CHU Clermont-Ferrand, Clermont-Ferrand, France
CHU Dijon-Bourgogne, Dijon, France
CHU Lille, Lille, France
HCL - Groupement Hospitalier Est, Hôpital Femme Mère Enfant, Lyon, France
AP-HM Hôpital de la Conception, Marseille, France
AP-HM Hôpital Nord, Marseille, France
CHU Montpellier, Montpellier, France
CHRU Nancy, Nancy, France

Showing 10 of 21 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-22.