Treatment Preventive for Pre-eclampsia by Acetylsalicylic Acid in Women Who Underwent Frozen Embryo Transfer

NCT ID: NCT05460416

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2026-06-30

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

Detailed Description

Method: Prospective, interventional, multicentric randomized controlled trial, to evaluate the utility of a preventive treatment with low dose acetylsalicylic acid from the embryo transfer and throughout pregnancy in patients who have had a frozen embryo transfer.

During the first consultation, patients will be introduced to the study. They can choose to participate or not. If they agree to participate, they will be randomized in two groups (1:1), treated or not. The randomization will be realized by the RedCap software. Patients with natural and modified natural cycle and hormone replacement treatment (HRT) cycle will be included. As soon as an evolutive intrauterine pregnancy is diagnosed, in the treated group, she will receive a daily dose of 160mg acetylsalicylic acid, until 36 weeks of amenorrhea. Patients of both groups will be followed twice a month (regular prenatal visit and phone call).

Primary goal: To assess the incidence of pre-eclamspia in women who underwent a frozen embryo transfer treated with 160mg of acetylsalicylic acid versus no treatment.

Primary endpoint: Mean number of women suffering from preeclampsia in the treated and not treated groups.

Secondary goals:

• To assess the incidence of pre-eclampsia in women who underwent a frozen embryo transfer in natural and modified natural cycle treated with 160mg acetylsalicylic acid versus without treatment Secondary Endpoint 1: mean number of women suffering from pre-eclampsia in treated and without treatment groups in women in natural and modified natural cycle
• To assess the incidence of pre-eclampsia in women who underwent a frozen embryo transfer in HRT cycle treated with 160mg acetylsalicylic acid versus without treatment Secondary Endpoint 2: mean number of women suffering from pre-eclampsia in treated and without treatment groups in women in HRT cycle
• To assess the number of miscarriage in frozen embryo transfer with natural and modified natural cycle and with HRT cycle.

Secondary Endpoint 3: mean number of miscarriage

• To assess the number of pre-eclampsia in frozen embryo transfer with natural and modified natural cycle and with HRT cycle.

Secondary Endpoint 4: mean number of pre-eclampsia

Duration: the study duration for the participant will be maximum 12 months (from inclusion before embryo transfer until delivery). The total duration study will be maximum 4 years from the first patient first inclusion visit until the last visit of study patient.

Number of participants: 120 patients per group, HRT cycle versus without treatment, spontaneous cycle vs without treatment. Due to miscarriage risk, a total of 276 women will be enrolled.

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

Conditions

Embryo Transfer; Hypertension, Pregnancy Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Treatment by acetylsalicylic acid

Group Type: EXPERIMENTAL

Acetylsalicylic acid

Intervention Type: DRUG

160mg once a day

No treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acetylsalicylic acid

160mg once a day

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Liege

OTHER

Sponsor Role: lead

Responsible Party

Julie Collee

Doctor, specialist in Obstetrics and Reproductive Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurie Henry

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Régional de la Citadelle

Locations

Centre Hospitalier Universitaire de Liège site Citadelle

Liège, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Julie Collée

Role: CONTACT

julie.collee@uliege.be

+32498973386

Marie Timmermans

Role: CONTACT

marie.timmermans@chuliege.be;

Facility Contacts

Julie Collée

Role: primary

julie.collee@uliege.be

Other Identifiers

2024-516816-72-00

Identifier Type: CTIS

Identifier Source: secondary_id

2021/392

Identifier Type: -

Identifier Source: org_study_id