Understanding pre-eclampsia risk in patients using assisted reproductive technology
At High-risk for Pre-eclampsia After Assisted Reproductive Technology
This study is trying to understand the risk of pre-eclampsia in women with polycystic ovary syndrome who are using assisted reproductive technology to help improve their pregnancy care and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1050 (estimated) |
| Ages | 18 Years to 48 Years |
| Sex | Female |
| Sponsor | CRG UZ Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05746793 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include first-time oocyte acceptors or nulliparous patients with PCOS undergoing ART.
Not a fit: Patients with known essential hypertension or those who develop new-onset hypertension before 20 weeks of gestation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized prenatal care and new prevention strategies for pre-eclampsia, reducing associated morbidity and mortality.
How similar studies have performed: Other studies have indicated a heightened risk of pre-eclampsia in ART patients, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brussels
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.