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NCT05746793Recruiting

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

Source: ClinicalTrials.gov · Last updated 28 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1050 (estimated)
First submitted
7 Nov 2022
Start date
15 Feb 2023
Primary completion date
1 Oct 2026
Lead sponsor
CRG UZ Brussel
NCT number
NCT05746793

What you commit to

  • Study type: Observational
  • Planned participants: 1050
  • From 15 Feb 2023 to the primary completion date, 1 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Thyroid dysfunction not under control with medication:
    • Hyperthyroidism, the diagnoses is made when:
  • History of prior pre-eclampsia

Other illness

  • Known essential hypertension or development of a new-onset hypertension before 20 weeks' gestation
    • Hypertension is defined as a systolic blood pressure ≥ 140 or a diastolic blood pressure ≥ 90 on two separate measurements with at least 20 minutes in between, taken when the patients is in a seated position Or
    • The patient is known with hypertension, diagnosed by a certified doctor
  • Other endocrinological disorder (including Cushing syndrome, Adrenal insufficiency, acromegaly): for diagnosis we will trust the opinion of the certified endocrinologist
  • Cardiovascular diseases (including coronary artery disease, arrhythmia, heart valve disease and heart failure): for diagnosis we will trust the opinion of the certified cardiologist
  • Renal disease/insufficiency: for diagnosis we will trust the opinion of the certified nephrologist
  • Antiphospholipid syndrome: for diagnosis we will trust the opinion of the certified internal medicine doctor
  • Liver dysfunction/disease: for diagnosis we will trust the opinion of the certified gastroenterologist
  • Women pregnant with a fetus with known abnormalities such chromosomal anomalies, structural deformities of limbs or organs or any other prebirth diagnosed syndromes or defects

Lab values

  • Known diabetes type 1 or 2 before pregnancy
    • Diagnosis of diabetes is confirmed when one of the following is present:
    • Fasting glucose ≥ 126 mg/dl
    • A 2-hour plasma glucose level ≥ 200 mg/dL during a 75-g oral glucose tolerance test Or
    • The patient is known with diabetes (type 1 or 2), diagnosed by a certified doctor

Other

  • Peripheral blood TSH \<0,5 mIU/L and fT4 \>1,9 ng/dl Or
  • When the patient is known with hyperthyroidism diagnosed by a certified physician
    • Hypothyroidism, the diagnosis is made when:
    • Peripheral blood TSH \>5 mIU/L and fT4 \<0,7 ng/dl Or
    • When the patient is known with hypothyroidism diagnosed by a certified physician
  • Systemic lupus erythematosus: for diagnosis we will trust the opinion of the certified internal medicine doctor
  • Multiple pregnancy

Who the study is looking for

  • First time oocyte acceptors Or Nulliparous PCOS patients undergoing ART (IVF/ICSI)
  • Criteria for PCOS: two out of the three following criteria must be present:
    • Oligo-or anovulation: a menstrual cycle \>35 days
    • Hyperandrogenism:
    • Clinically: the presence of hirsutism and/ or severe acne in combination with alopecia confirmed hyperandrogenism Or
    • Biochemically: serum total testosterone \>52 ng/dl or calculated free testosterone \>0,64 ng/dl
    • Polycystic ovaries:
    • Follicle number per ovary (FNPO) ≥ 12 on both ovaries Or
    • Ovarian volume ≥ 10 ml in both ovaries Or
    • One ovary with ≥ 20 follicles (Using endovaginal US transducers with a frequency bandwidth that includes 8 MHz) Or
    • AMH ≥ 4,9 ng/ml

Age in the registry: 18 years to 48 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Brussels IVF
Coordinator of this site? Confirm its status
BrusselsBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.