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

RecruitingOBSERVATIONAL
Enrollment

1,050

Participants

Timeline

Start Date

February 15, 2023

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2027

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."

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

nutritional and metabolic work-up

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

DIAGNOSTIC_TEST

cardiac work-up

Using transthoracic ultrasound.

DIAGNOSTIC_TEST

Blood pressure measurement

Blood pressure measurement

Trial Locations (1)

1090

RECRUITING

Brussels IVF, Brussels

All Listed Sponsors
lead

CRG UZ Brussel

OTHER