Actively Recruiting
At High-risk for Pre-eclampsia After Assisted Reproductive Technology
Led by CRG UZ Brussel · Updated on 2023-03-28
1050
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating pre-eclampsia (PE) in women at high risk following assisted reproductive technology (ART), focusing on patients with polycystic ovary syndrome (PCOS) and oocyte recipients. The study aims to better understand the causes and risk factors of PE to improve prenatal care and find new prevention methods. The project is divided into work packages that study maternal characteristics before pregnancy, pregnancy screening and monitoring, and placental molecular pathways at delivery. The study involves detailed assessments including blood collection, endometrial biopsy, ultrasound, and urine sampling. Participants will undergo a MOCK frozen embryo transfer preparative cycle with hormone treatments and sample collections. During pregnancy, patients will be screened for PE risk using the Fetal Medicine Foundation first trimester screening, and aspirin may be advised for those at high risk. Follow-up visits occur at several points during pregnancy, and biological samples are collected at delivery for research. Participants will be involved in various tests such as blood pressure monitoring, cardiac and nutritional evaluations, ultrasounds, and questionnaires from preconception through pregnancy and delivery. Researchers will measure a wide range of outcomes including PE incidence and severity, fetal growth, gene expression in placental tissues, and cardiovascular parameters. The study spans from preconception through delivery and includes extensive clinical and molecular data collection to understand PE development in high-risk ART patients.
CONDITIONS
Brief Title
At High-risk for Pre-eclampsia After Assisted Reproductive Technology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First-time oocyte recipients or nulliparous PCOS patients undergoing assisted reproductive technology (IVF/ICSI)
- For PCOS diagnosis, at least two of the following must be present:
- Menstrual cycles longer than 35 days (oligo- or anovulation)
- Clinical signs of high androgen levels (hirsutism, severe acne with alopecia) or biochemical evidence (serum total testosterone >52 ng/dl or free testosterone >0.64 ng/dl)
- Polycystic ovaries shown by ultrasound or high AMH levels (≥4.9 ng/ml)
You will not qualify if you...
- Known essential hypertension or new-onset hypertension before 20 weeks of gestation
- Known type 1 or type 2 diabetes before pregnancy
- Uncontrolled thyroid dysfunction (hyperthyroidism or hypothyroidism) despite medication
- Other endocrine disorders (e.g., Cushing syndrome, adrenal insufficiency, acromegaly)
- Cardiovascular diseases (including coronary artery disease, arrhythmia, heart valve disease, heart failure)
- Renal disease or insufficiency
- Systemic lupus erythematosus
- Antiphospholipid syndrome
- Liver dysfunction or disease
- History of previous pre-eclampsia
- Pregnancy with fetus having known abnormalities or syndromes
- Multiple pregnancy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to ART treatment start
Duration - Approximately 1 menstrual cycle (4 weeks)
Participants undergo preconception assessments including baseline questionnaire, nutritional and metabolic evaluation, cardiac work-up, blood pressure measurement, peripheral blood collection, and ultrasound examinations during a MOCK frozen embryo transfer preparative cycle. Endometrial biopsy and menstrual blood collection are also performed to gather tissue and biological samples.
Several visits including MOCK preparative cycle monitoring and biopsy visits
Duration - From 7 to 36 weeks of gestation
During pregnancy, participants are monitored at multiple time points with urine collection, blood analysis, blood pressure measurement, cardiac and nutritional work-ups, and ultrasound evaluations to assess risk and development of pre-eclampsia.
Visits at approximately 7, 12, 20, 28, and 36 weeks' gestation
Duration - At time of delivery
At delivery, placental tissue, membranes, umbilical cord tissue, and cord blood are collected for research analysis to study molecular pathways related to pre-eclampsia development.
1 visit (in-person) at delivery
Trial Site Locations
Total: 1 location
1
Brussels IVF
Brussels, Belgium, 1090
Actively Recruiting
Research Team
S
Study nurses Brussels IVF
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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