NCT05460416 Treatment Preventive for Pre-eclampsia by Acetylsalicylic Acid in Women Who Underwent Frozen Embryo Transfer
| NCT ID | NCT05460416 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire de Liege |
| Condition | Embryo Transfer |
| Study Type | INTERVENTIONAL |
| Enrollment | 276 participants |
| Start Date | 2022-10-25 |
| Primary Completion | 2025-12-31 |
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 276 participants in total. It began in 2022-10-25 with a primary completion date of 2025-12-31.
⚠ 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
Title: A prospective multicentric interventional randomized controlled trial to assess the effect of low dose acetylsalicylic acid as a preventive treatment of pre-eclampsia in pregnant women who underwent frozen embryo transfer
Eligibility Criteria
Inclusion Criteria: * Healthy women from \[18 - 43\] years-old, planned for a frozen embryo transfer, with natural and modified natural or HRT cycle * Who have given their informed consent * Who have a confirmed pregnancy at week 6 of amenorrhea. Exclusion Criteria: * Women presenting one risk factor for preeclampsia: multiple pregnancy, history of preeclampsia, BMI \> 30, lupus syndrome, preexistent proteinuria, non-treated chronic high blood pressure (\>140/90), antiphospholipid antibody syndrome, diabetes (fasting blood sugar \>126mg/dl) * Contraindication to acetylsalicylic acid (at risk of active hemorrhage (like hemophilia, …); at risk of or who have a gastro-duodenal ulcer; at risk or how have a terminal renal or hepatic in-sufficiency (only if acetylsalicylic acid is given at high dose) * Already treated with acetylsalicylic acid * Treatment with anticoagulants or non-steroid anti-inflammatory drugs
Contact & Investigator
Laurie Henry
PRINCIPAL INVESTIGATOR
Centre Hospitalier Régional de la Citadelle
Frequently Asked Questions
Who can join the NCT05460416 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 43 Years, studying Embryo Transfer. 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 NCT05460416 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 276 participants.
Is NCT05460416 currently recruiting?
Yes, NCT05460416 is actively recruiting participants. Contact the research team at julie.collee@uliege.be for enrollment information.
Where is the NCT05460416 trial being conducted?
This trial is being conducted at Liège, Belgium.
Who is sponsoring the NCT05460416 clinical trial?
NCT05460416 is sponsored by Centre Hospitalier Universitaire de Liege. The principal investigator is Laurie Henry at Centre Hospitalier Régional de la Citadelle. The trial plans to enroll 276 participants.