RecruitingNCT05746793

At High-risk for Pre-eclampsia After Assisted Reproductive Technology


Sponsor

CRG UZ Brussel

Enrollment

1,050 participants

Start Date

Feb 15, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The overarching goal of the project is to unravel PE etiopathogenesis in high-risk patients (PCOS patients and oocyte acceptors) after assisted reproductive technology (ART) to individualize prenatal care following ART and to determine potential targets for new PE prevention options decreasing the morbidity/mortality caused by this pathology. More specifically, the following objectives/work packages (WPs) are put forward: * WP1 - PRECONCEPTION: Identify preconceptional maternal characteristics associated with in-creased risk of PE in ART patients (1a) and investigate the potential role of the endometrium prior to pregnancy (1b). * WP2 - DURING PREGNANCY: Evaluate the Fetal Medicine Foundation's (FMF) first trimester PE screening in selected high-risk groups post ART to explore the clinical benefit in this specific context (2a) and investigate the association between parameters during the pregnancy and PE development post-ART. * WP3 - AT DELIVERY: Identifying placental molecular pathways associated with PE post-ART.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 48 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at women with polycystic ovary syndrome (PCOS) who are undergoing IVF or ICSI (fertility treatments) to understand their risk of developing pre-eclampsia (a dangerous high blood pressure condition during pregnancy) and find ways to reduce that risk. **You may be eligible if...** - You are undergoing IVF or ICSI for the first time as an egg recipient, OR - You have PCOS (diagnosed with at least 2 of the 3 standard criteria: irregular periods, signs of high androgens, or polycystic ovaries on ultrasound) and are having IVF/ICSI for the first time **You may NOT be eligible if...** - You already have high blood pressure (hypertension) or develop it before 20 weeks of pregnancy - You have pre-existing Type 1 or Type 2 diabetes - You have known kidney disease, autoimmune disease, or antiphospholipid syndrome - You have had a previous pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREendometrium biopsy

The procedure is performed without any anesthesia and takes approximately 5 minutes. A small plastic pipelle is put through the cervix into the uterine cavity. The endometrial tissue is aspirated into the pipelle.

DIAGNOSTIC_TESTTransabdominal ultrasound

Evaluation of fetal biometry and doppler flow study using ultrasound.

DIAGNOSTIC_TESTPeripheral phlebotomy

single puncture collection of peripheral venous blood.

DIAGNOSTIC_TESTUrine collection

Collection of urine in a plastic cup.

OTHERMOCK frozen embryo transfer preparative cycle.

Start with daily estradiol (progynova, oestrogel) administration at hormonal baseline (day 2 of the cycle or with confirmation using endocrine evaluation). When adequate thickness (≥6.5 mm) of the endometrium is achieved (usually after 10-14 days), progesterone is administered daily. 6 days after progesterone administration, the pipelle biopsy will be performed. When this test cycle has ended and menstruation starts, patients will be asked to collect their menstrual flow, during the first night of heavy/red flow, in a menstrual cup. The next day patients will be asked to bring their collected menstrual blood to our center and they will undergo a blood analysis needed for the start of their ART treatment.

DIAGNOSTIC_TESTBaseline questionnaire

questionnaire the patient has to fill in

OTHERcollection of menstrual blood

collection of menstrual blood during the first day of heavy menstrual flow for at least 6 hours

DIAGNOSTIC_TESTnutritional and metabolic work-up

Including body composition analysis by BIA/whole body MRI and analysis of resting energy expenditure (REE).

DIAGNOSTIC_TESTcardiac work-up

Using transthoracic ultrasound.

DIAGNOSTIC_TESTBlood pressure measurement

Blood pressure measurement


Locations(1)

Brussels IVF

Brussels, Belgium

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NCT05746793


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