Understanding pre-eclampsia risk in patients using assisted reproductive technology

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the causes of pre-eclampsia (PE) in high-risk patients, specifically those with polycystic ovary syndrome (PCOS) and first-time oocyte acceptors undergoing assisted reproductive technology (ART). The study will assess maternal characteristics before conception, evaluate first trimester screening for PE, and analyze placental factors at delivery. By identifying risk factors and potential preventive measures, the research seeks to improve prenatal care and outcomes for mothers and their children. Various interventions, including endometrium biopsies and ultrasounds, will be utilized throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  1. Oligo-or anovulation: a menstrual cycle \>35 days
  2. 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
  3. 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

Exclusion Criteria:

* 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
* 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
* Thyroid dysfunction not under control with medication:

  * Hyperthyroidism, the diagnoses is made when:
* 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
* 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
* Systemic lupus erythematosus: for diagnosis we will trust the opinion of the certified internal medicine doctor
* 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
* History of prior pre-eclampsia
* 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
* Multiple pregnancy

Where it's running

• Brussels IVF
  Brussels, Belgium Recruiting

Study contacts

• Principal investigator: Shari Mackens, PhD, MD — Medical director Brussels IVF
• Study coordinator: Study nurses Brussels IVF
• Email: studieverpleegkundigen_crg@uzbrussel.be
• Phone: +32 2 477 66 99

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• How the placenta affects maternal and fetal health

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.