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

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.

Conditions

• Pre-Eclampsia

Interventions

PROCEDURE

endometrium 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.

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Transabdominal ultrasound

Evaluation of fetal biometry and doppler flow study using ultrasound.

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Peripheral phlebotomy

single puncture collection of peripheral venous blood.

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Urine collection

Collection of urine in a plastic cup.

OTHER

MOCK 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.

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Baseline questionnaire

questionnaire the patient has to fill in

OTHER

collection of menstrual blood

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

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nutritional and metabolic work-up

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

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cardiac work-up

Using transthoracic ultrasound.

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Blood pressure measurement

Blood pressure measurement

Sponsors & Collaborators

• CRG UZ Brussel

  lead OTHER

Principal Investigators

• Shari Mackens, PhD, MD · Medical director Brussels IVF

Eligibility

Min Age

18 Years

Max Age

48 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-15

Primary Completion

2026-10-01

Completion

2027-10-01

Countries

• Belgium

Study Locations