NCT05625724 Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology
| NCT ID | NCT05625724 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Toulouse |
| Condition | ART |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,164 participants |
| Start Date | 2023-08-02 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,164 participants in total. It began in 2023-08-02 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Christophe VAYSSIERE, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT05625724 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying ART. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05625724 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,164 participants.
Is NCT05625724 currently recruiting?
Yes, NCT05625724 is actively recruiting participants. Contact the research team at guerby.p@chu-toulouse.fr for enrollment information.
Where is the NCT05625724 trial being conducted?
This trial is being conducted at Angers, France, Bordeaux, France, Clermont-Ferrand, France, Dijon, France and 11 additional locations.
Who is sponsoring the NCT05625724 clinical trial?
NCT05625724 is sponsored by University Hospital, Toulouse. The principal investigator is Christophe VAYSSIERE, MD at University Hospital, Toulouse. The trial plans to enroll 1,164 participants.