Embryo TransferPhase 3TePPAFETNCT05460416
Treatment Preventive for Pre-eclampsia by Acetylsalicylic Acid in Women Who Underwent Frozen Embryo Transfer
A Phase 3 study testing Acetylsalicylic acid in people with Embryo Transfer and Hypertension, Pregnancy Induced, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Embryo Transfer, Hypertension, Pregnancy Induced
- What is being tested?
- Acetylsalicylic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Oct 2022to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie Timmermans contact
Belgium1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Liège site Citadelle
Liège
Julie Collée, julie.collee@uliege.be
About this study
Official title: A Prospective 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
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
Read the 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
- Being tested
- Acetylsalicylic acid
- Keywords
- embryo transfer, Hypertension, Pregnancy induced
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acidDrug
160mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Treatment by acetylsalicylic acid | Experimental | Not described Receives: Drug: Acetylsalicylic acid |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of women suffering from pre-eclampsia in the treated and not treated groups.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start25 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo TransferStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Collee, Centre Hospitalier Régional de la Citadelle
- Investigators
- Laurie Henry, Principal investigator, Centre Hospitalier Régional de la Citadelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460416
- Sponsor's protocol ID
- 2021/392
- Other IDs
- 2024-516816-72-00
- Acronym
- TePPAFET
- Status last verified
- Feb 2025
- First submitted
- 11 Jul 2022
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective 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
- ClinicalTrials.gov ID
- NCT05460416
- Acronym / sponsor ID
- TePPAFET / 2021/392
- Conditions
- Embryo Transfer, Hypertension, Pregnancy Induced
- Keywords
- embryo transfer, Hypertension, Pregnancy induced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment by acetylsalicylic acid | Experimental | Drug: Acetylsalicylic acid |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic acid160mg once a day | Drug | Treatment by acetylsalicylic acid |
Primary outcome
Mean number of women suffering from pre-eclampsia in the treated and not treated groups.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
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Linzagolix in Adenomyosis and Recurrent Implantation Failure
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Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie Timmermans contact
Laurie Henry principal investigator
Centre Hospitalier Régional de la Citadelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic acid in people with Embryo Transfer and Hypertension, Pregnancy Induced, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Collée (+32498973386, julie.collee@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of women suffering from pre-eclampsia in the treated and not treated groups. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.