Pre-EclampsiaHEARTNCT05746793
At High-risk for Pre-eclampsia After Assisted Reproductive Technology
An observational study of Pre-Eclampsia, run by CRG UZ Brussel at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- endometrium biopsy, Transabdominal ultrasound and Peripheral phlebotomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,050 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2023to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients at high-risk of developing PE and planned to undergo ART: * Oocyte recipients: patients are planned to undergo a transfer of an embryo conceived with a donor oocyte * PCOS patients: patients diagnosed with polycystic ovary syndrome (Rotterdam criteria) and planned to undergo a IVF/ICSI or IVM treatment
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Brussels IVF
Brussels, 1090
Study nurses, +32 2 477 66 99, studieverpleegkundigen_crg@uzbrussel.be
Shari Mackens, PhD, MD
About this study
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.
Read the detailed description
Background:
Pre-eclampsia (PE) is a multisystemic syndrome occurring in 4-5% of pregnant women. It is defined by a new-onset hypertension (HT) developing after 20 weeks of gestation in combination with one of the following entities: proteinuria, maternal organ dysfunction and/or uteroplacental insufficiency. The vicious circle of the syndrome can end up in life-threatening complications for mother and child and, today, the only treatment of cure is the induction of delivery. Furthermore, besides the problems in the acute phase of the disease, women who experienced PE have been shown to have an increased lifetime risk of developing cardiovascular disease (CVD) and chronic kidney disease, while the children carry the consequences of their prematurity and, often following intra-uterine growth restriction, also seem to be more prone to develop metabolic disturbances like diabetes, HT and CVD later in life. Research, including data publishes by my own research group, shows that the risk of PE development in subfertile patients undergoing assisted reproductive technology (ART), is more than doubled, with incidences between 8-12%.
ART includes in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), using autologous or heterologous gametes, followed by fresh or frozen embryo transfer. The increased risk of PE within this population has mainly been attributed to known maternal PE risk factors associated with ART like increased maternal age, nulliparity and metabolic disturbances e.g. in patients with polycystic ovary syndrome (PCOS). Recent studies however have shown that ART is an independent risk factor of PE. More specifically, a higher PE incidence is consistently observed when patients have a frozen embryo transfer (FET) in an artificially prepared cycle. Unlike in a natural cycle in which ovulation occurs, an artificial cycle is characterized by the absence of ovulation as the luteal phase is induced by exogenous progesterone administration. It has been put forward that the absence of the corpus luteum, producing vasoactive and angiogenic substances (e.g. VEG-F, relaxin) and thereby orchestrating a correct placental development, could be held responsible for this observation. Other high risk ART patients are recipients of heterologous oocytes (i.e. oocyte recipients) potentially due to immunological conflicts.
In 2016, the ASPRE trial published their results evaluating a new first trimester screening tool developed by the fetal medicine foundation (FMF). This algorithm takes into account a limited number of anamnestic maternal characteristics, maternal blood pressure, the measurement of placental growth factor (PlGF) as a serum biomarker and the ultrasonographic measurement of the pulsatility index of the uterine artery. When an increased risk of PE had been detected (>1/100), aspirin daily is given, starting before 16 weeks' of gestation.
As of May 2021, the FMF first trimester screening for PE is offered in the Brussels IVF fertility clinic to all the above-described high-risk patients pregnant following ART (PCOS and oocyte recipients included). Preliminary data confirm a high incidence of positive screening with an overall risk of 18%, reaching upto 27% in oocyte recipients (compared to the reported 10% in the general population following spontaneous conception). To the best of our knowledge, the applicability of the screening tool and aspirin administration for PE prevention has never been specifically evaluated post-ART. PE etiopathogenesis is complex and the exact molecular causative processes are still being unraveled. PE has a wide range of clinical presentations and it is currently unknown what drives these differences. Of critical importance for instance is the difference between early onset pre-eclampsia (EOPE), defined as PE occurring before 34 weeks of gestation and late onset pre-eclampsia (LOPE), defined as PE occurring at or after 34 weeks of gestation. In EOPE, which is mainly a placental disease, the impaired invasion of the spiral arteries by the extravillous cytotrofoblast cells has been put forward as the key pathophysiological component. This in contrary to LOPE, which is seen as a maternal disease, where there is a discrepancy between fetal growth, aging of the placenta an the maternal supply and cardiovascular reserve. Further, single-cell RNA sequencing on placentas confirmed the extensive different expressed genes between EOPE and LOPE. Also, the role of different serum markers (PlGF, sFLT-1, VEGF, leptin, annexin…) have been studied, but their contribution to EOPE and LOPE still remains unclear.
Lastly, very limited but intriguing research data suggest that the preconceptional endometrium could be implicated in PE development during pregnancy, with the focus on impaired decidualization and its role in PE origin. Given the differences in patient characteristics between the above-mentioned ART subgroups at risk for PE, our research team expects their PE-etiopathogenesis to be diverse. Though the multidisciplinary approach of this project, both on a clinical and fundamental research level, we hope to unravel pre-eclampsia, a multifactorial disease, and this in specific relation to different ART high-risk groups. This way, ultimately, the results will point towards targets for prevention and treatment of PE following ART and will contribute to a decrease in the morbidity and mortality associated with this devastating disease, for which, currently, no cure but termination of the pregnancy is available.
Hypothesis:
Work package 1a: there is a significant difference in preconceptional maternal characteristics between ART patients screening positive/developing PE and ART patients screening negative/not developing PE and these identified risk factors are specific for each ART subgroup.
Work package 1b: preconceptionally harvested endometrial tissue/stromal cells/organoids harbor significant differences in function of the subsequent (i.e. during pregnancy) negative or positive PE screening, PE development and specific high-risk ART group.
Work package 2a: the incidence of a positive screening/PE development (EOPE vs. LOPE) differs significantly among different ART groups.
Work package 2b: parameters during the pregnancy (blood pressure, biomarkers in the blood, ultrasound, nutritional and cardiac parameters) are significantly different between ART patients screening positive/developing PE and these identified parameters are specific for each ART subgroup.
Work package 3: placental tissue, membranes, cord tissue and cord blood harbor significant differences in expressed molecular pathways depending on negative or positive PE screening, PE development or not and are specific for the high-risk ART group.
Experimental design:
Prospective interventional cohort study without the use of a product nor medical device.
Methodology:
The study population will be subdivided into two different patient groups. Patients will be asked to participate to the study when they are planning to undergo ART and are (already prior to the start of their treatment) suspected to be at higher risk for the development PE after achieving pregnancy:
- Group 1 will include oocyte recipients as the use of donor oocytes predisposes them to a potential immunological conflict during pregnancy contributing to PE development
- Group 2 will include PCOS patients as endocrine and metabolic abnormalities predispose them to an abnormal trophoblast invasion contributing to PE development Work package 1a: evaluation of maternal baseline characteristics, laboratory studies, ultrasound examination, cardiac and nutritional work-up.
Work package 1b: harvesting and biobanking of preconceptional endometrium during the luteal phase of a preparative non-conceptional test-ART cycle (MOCK cycle). Depending on the outcome of the pregnancy, tissue can be thawed and used for basic research experiments (stromal cell lines, organoids, decidualization experiments, implantation experiments).
Work package 2a: patients are screened between 11- and 14-weeks' gestation using the FMF PE screening algorithm (routine care at our center). When patients are determined to be at high-risk of PE development (>1/100), they are advised to take aspirin (160 mg daily) until 36 weeks' gestation.
Work package 2b: patients will be followed up at different time points during their pregnancy (7, 12, 20, 28, 36 weeks' gestation) using urine sampling, blood analysis, blood pressure measurement, cardiac and nutritional work-up and ultrasound evaluation.
Work package 3: collection of placental tissue, membranes, umbilical cord tissue and cord blood at time of delivery for basic research analysis. Evaluation of different molecular pathways and expressed genes between no PE, EOPE and LOPE and this in specific relation to the different high-risk groups.
- Conditions
- Pre-Eclampsia
- Being tested
- endometrium biopsy, Transabdominal ultrasound, Peripheral phlebotomy, Urine collection, MOCK frozen embryo transfer preparative cycle.
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrium biopsyProcedure or surgery
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.
Transabdominal ultrasoundDiagnostic test
Evaluation of fetal biometry and doppler flow study using ultrasound.
Peripheral phlebotomyDiagnostic test
single puncture collection of peripheral venous blood.
Urine collectionDiagnostic test
Collection of urine in a plastic cup.
MOCK frozen embryo transfer preparative cycle.Other
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.
Baseline questionnaireDiagnostic test
questionnaire the patient has to fill in
collection of menstrual bloodOther
collection of menstrual blood during the first day of heavy menstrual flow for at least 6 hours
nutritional and metabolic work-upDiagnostic test
Including body composition analysis by BIA/whole body MRI and analysis of resting energy expenditure (REE).
cardiac work-upDiagnostic test
Using transthoracic ultrasound.
Blood pressure measurementDiagnostic test
Blood pressure measurement
| Study group | Role | What they receive |
|---|---|---|
| Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment | Peripheral blood collection. MOCK frozen embryo preparative cycle. Endometrial pipelle biopsy. Collection of menstrual blood. Questionnaire. Nutritional/metabolic evaluation. Cardiac work-up. Preconceptional and prenatal ultrasound. Blood pressure measurements. Urine analysis. Receives: Procedure: endometrium biopsy; Diagnostic Test: Transabdominal ultrasound; Diagnostic Test: Peripheral phlebotomy; Diagnostic Test: Urine collection; Other: MOCK frozen embryo transfer preparative cycle.; Diagnostic Test: Baseline questionnaire; Other: collection of menstrual blood; Diagnostic Test: nutritional and metabolic work-up; Diagnostic Test: cardiac work-up; Diagnostic Test: Blood pressure measurement | |
| Oocyte acceptors | Peripheral blood collection. MOCK frozen embryo preparative cycle. Endometrial pipelle biopsy. Collection of menstrual blood. Questionnaire. Nutritional/metabolic evaluation. Cardiac work-up. Preconceptional and prenatal ultrasound. Blood pressure measurements. Urine analysis. Receives: Procedure: endometrium biopsy; Diagnostic Test: Transabdominal ultrasound; Diagnostic Test: Peripheral phlebotomy; Diagnostic Test: Urine collection; Other: MOCK frozen embryo transfer preparative cycle.; Diagnostic Test: Baseline questionnaire; Other: collection of menstrual blood; Diagnostic Test: nutritional and metabolic work-up; Diagnostic Test: cardiac work-up; Diagnostic Test: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (kg/m2)
measurement of height en weight. Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
Measured: 1 year
Total energy expenditure (kcal/day)
Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
Measured: 1 year
number of laps of 6MWT (number)
6 minute walking test Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
Measured: 1 year
Saturation beginning and end of 6MWT (%)
6 minute walking test Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
Measured: 1 year
pulse beginning and end of 6MWT
6 minute walking test Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
Measured: 1 year
Effective maximal handgrip strength (KPa)
Hangrip strenght Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
Measured: 1 year
Time until 50% of effective handgrip strenght (s)
Hangrip strenght Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
Measured: 1 year
IVSd (mm)
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
PWTd (mm)
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
LVEDD (mm)
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
IVSs (mm)
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
PWTs (mm)
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
LVESD (mm)
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
LV mass (indexed) mg/m2
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
LVEF (visual, manual modified Simpson's biplane, auto-EF) (%)
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
LV GLS (LV MW) (-%)
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
E-wave velocity (cm/s)
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
A-wave velocity (cm/s)
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
Deceleration time (ms)
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
E/A ratio
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
Septal wall e' (cm/s)
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
Lateral wall e' (cm/s)
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
E/e' ratio
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
Septal e'/lateral e' ratio
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
LA AP diameters (mm)
Transthoracic ultrasound Evaluation of left atrium Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
LAESVi (mL/M2)
Transthoracic ultrasound Evaluation of left atrium Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
La strain (-%)
Transthoracic ultrasound Evaluation of left atrium Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
TAPSE (mm)
Transthoracic ultrasound Evaluation of right ventricle and RV systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
RV s' (cm)
Transthoracic ultrasound Evaluation of right ventricle and RV systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
RV GLS (RV MW) (-%)
Transthoracic ultrasound Evaluation of right ventricle and RV systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Measured: 1 year
systolic, diastolic bloodpressure and mean arterial pressure (mmHg)
Blood pressure measurement device. Work package 1: preconception Work package 2: during pregnancy
Measured: 1 year
Pulsatility index of the uterine artery
ultrasound Work package 1: preconception Work package 2: during pregnancy
Measured: 1 year
(sub)endometrial flow (1,2,3)
ultrasound Work package 1: preconception Work package 2: during pregnancy
Measured: 1 year
PRL mRNA expression
RNA sequencing Work package 1: preconception
Measured: 3 months
PRL production (ng/ml)
ELISA Work package 1: preconception
Measured: 3 months
IGFBP1 mRNA expression
RNA sequencing Endometrial tissue Work package 1: preconception
Measured: 3 months
IGFBP1 (pg/ml)
ELISA Endometrial tissue Work package 1: preconception
Measured: 3 months
PlGF (pg/ml)
blood sample Work package 1: preconception Work package 2: during pregnancy
Measured: 3 months
sFLT1 (pg/ml)
blood sample Work package 1: preconception Work package 2: during pregnancy
Measured: 3 months
sENG (ng/ml)
blood sample Work package 1: preconception Work package 2: during pregnancy
Measured: 3 months
Incidence of positive PE screening (%)
Fetal medicine foundation screening algorithm. Work package 2: during pregnancy
Measured: 6 months
Estimated fetal weight (g)
ultrasound Work package 2: during pregnancy
Measured: 1 year
PI umbilical artery
ultrasound Work package 2: during pregnancy
Measured: 1 year
PI uterine artery
ultrasound Work package 2: during pregnancy
Measured: 1 year
gestational age at diagnoses PE (weeks)
work package 2: during pregnancy
Measured: 1 year
incidence of PE (%)
work package 2: during pregnancy
Measured: 1 year
severity of PE (mild/severe)
work package 2: during pregnancy
Measured: 1 year
gestational age at delivery (weeks)
work package 3: at delivery
Measured: 1 year
birth weight (grams)
work package 3: at delivery
Measured: 1 year
APGAR scores of baby after 1, 5 and 10 minutes (1-10)
work package 3: at delivery
Measured: 1 year
different expressed genes (DEGs) of placenta's
work package 3: at delivery RNA sequencing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start15 Feb 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CRG UZ Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mackens Shari, CRG UZ Brussel
- Investigators
- Shari Mackens, PhD, MD, Principal investigator, Medical director Brussels IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746793
- Sponsor's protocol ID
- 22271HEART
- Acronym
- HEART
- Status last verified
- Mar 2023
- First submitted
- 7 Nov 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At High-risk for Pre-eclampsia After Assisted Reproductive Technology
- ClinicalTrials.gov ID
- NCT05746793
- Acronym / sponsor ID
- HEART / 22271HEART
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- CRG UZ BrusselUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Pre-eclampsia (PE) is a multisystemic syndrome occurring in 4-5% of pregnant women. It is defined by a new-onset hypertension (HT) developing after 20 weeks of gestation in combination with one of the following entities: proteinuria, maternal organ dysfunction and/or uteroplacental insufficiency. The vicious circle of the syndrome can end up in life-threatening complications for mother and child and, today, the only treatment of cure is the induction of delivery. Furthermore, besides the problems in the acute phase of the disease, women who experienced PE have been shown to have an increased lifetime risk of developing cardiovascular disease (CVD) and chronic kidney disease, while the children carry the consequences of their prematurity and, often following intra-uterine growth restriction, also seem to be more prone to develop metabolic disturbances like diabetes, HT and CVD later in life. Research, including data publishes by my own research group, shows that the risk of PE development in subfertile patients undergoing assisted reproductive technology (ART), is more than doubled, with incidences between 8-12%.
ART includes in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), using autologous or heterologous gametes, followed by fresh or frozen embryo transfer. The increased risk of PE within this population has mainly been attributed to known maternal PE risk factors associated with ART like increased maternal age, nulliparity and metabolic disturbances e.g. in patients with polycystic ovary syndrome (PCOS). Recent studies however have shown that ART is an independent risk factor of PE. More specifically, a higher PE incidence is consistently observed when patients have a frozen embryo transfer (FET) in an artificially prepared cycle. Unlike in a natural cycle in which ovulation occurs, an artificial cycle is characterized by the absence of ovulation as the luteal phase is induced by exogenous progesterone administration. It has been put forward that the absence of the corpus luteum, producing vasoactive and angiogenic substances (e.g. VEG-F, relaxin) and thereby orchestrating a correct placental development, could be held responsible for this observation. Other high risk ART patients are recipients of heterologous oocytes (i.e. oocyte recipients) potentially due to immunological conflicts.
In 2016, the ASPRE trial published their results evaluating a new first trimester screening tool developed by the fetal medicine foundation (FMF). This algorithm takes into account a limited number of anamnestic maternal characteristics, maternal blood pressure, the measurement of placental growth factor (PlGF) as a serum biomarker and the ultrasonographic measurement of the pulsatility index of the uterine artery. When an increased risk of PE had been detected (>1/100), aspirin daily is given, starting before 16 weeks' of gestation.
As of May 2021, the FMF first trimester screening for PE is offered in the Brussels IVF fertility clinic to all the above-described high-risk patients pregnant following ART (PCOS and oocyte recipients included). Preliminary data confirm a high incidence of positive screening with an overall risk of 18%, reaching upto 27% in oocyte recipients (compared to the reported 10% in the general population following spontaneous conception). To the best of our knowledge, the applicability of the screening tool and aspirin administration for PE prevention has never been specifically evaluated post-ART. PE etiopathogenesis is complex and the exact molecular causative processes are still being unraveled. PE has a wide range of clinical presentations and it is currently unknown what drives these differences. Of critical importance for instance is the difference between early onset pre-eclampsia (EOPE), defined as PE occurring before 34 weeks of gestation and late onset pre-eclampsia (LOPE), defined as PE occurring at or after 34 weeks of gestation. In EOPE, which is mainly a placental disease, the impaired invasion of the spiral arteries by the extravillous cytotrofoblast cells has been put forward as the key pathophysiological component. This in contrary to LOPE, which is seen as a maternal disease, where there is a discrepancy between fetal growth, aging of the placenta an the maternal supply and cardiovascular reserve. Further, single-cell RNA sequencing on placentas confirmed the extensive different expressed genes between EOPE and LOPE. Also, the role of different serum markers (PlGF, sFLT-1, VEGF, leptin, annexin…) have been studied, but their contribution to EOPE and LOPE still remains unclear.
Lastly, very limited but intriguing research data suggest that the preconceptional endometrium could be implicated in PE development during pregnancy, with the focus on impaired decidualization and its role in PE origin. Given the differences in patient characteristics between the above-mentioned ART subgroups at risk for PE, our research team expects their PE-etiopathogenesis to be diverse. Though the multidisciplinary approach of this project, both on a clinical and fundamental research level, we hope to unravel pre-eclampsia, a multifactorial disease, and this in specific relation to different ART high-risk groups. This way, ultimately, the results will point towards targets for prevention and treatment of PE following ART and will contribute to a decrease in the morbidity and mortality associated with this devastating disease, for which, currently, no cure but termination of the pregnancy is available.
Hypothesis:
Work package 1a: there is a significant difference in preconceptional maternal characteristics between ART patients screening positive/developing PE and ART patients screening negative/not developing PE and these identified risk factors are specific for each ART subgroup.
Work package 1b: preconceptionally harvested endometrial tissue/stromal cells/organoids harbor significant differences in function of the subsequent (i.e. during pregnancy) negative or positive PE screening, PE development and specific high-risk ART group.
Work package 2a: the incidence of a positive screening/PE development (EOPE vs. LOPE) differs significantly among different ART groups.
Work package 2b: parameters during the pregnancy (blood pressure, biomarkers in the blood, ultrasound, nutritional and cardiac parameters) are significantly different between ART patients screening positive/developing PE and these identified parameters are specific for each ART subgroup.
Work package 3: placental tissue, membranes, cord tissue and cord blood harbor significant differences in expressed molecular pathways depending on negative or positive PE screening, PE development or not and are specific for the high-risk ART group.
Experimental design:
Prospective interventional cohort study without the use of a product nor medical device.
Methodology:
The study population will be subdivided into two different patient groups. Patients will be asked to participate to the study when they are planning to undergo ART and are (already prior to the start of their treatment) suspected to be at higher risk for the development PE after achieving pregnancy:
- Group 1 will include oocyte recipients as the use of donor oocytes predisposes them to a potential immunological conflict during pregnancy contributing to PE development
- Group 2 will include PCOS patients as endocrine and metabolic abnormalities predispose them to an abnormal trophoblast invasion contributing to PE development Work package 1a: evaluation of maternal baseline characteristics, laboratory studies, ultrasound examination, cardiac and nutritional work-up.
Work package 1b: harvesting and biobanking of preconceptional endometrium during the luteal phase of a preparative non-conceptional test-ART cycle (MOCK cycle). Depending on the outcome of the pregnancy, tissue can be thawed and used for basic research experiments (stromal cell lines, organoids, decidualization experiments, implantation experiments).
Work package 2a: patients are screened between 11- and 14-weeks' gestation using the FMF PE screening algorithm (routine care at our center). When patients are determined to be at high-risk of PE development (>1/100), they are advised to take aspirin (160 mg daily) until 36 weeks' gestation.
Work package 2b: patients will be followed up at different time points during their pregnancy (7, 12, 20, 28, 36 weeks' gestation) using urine sampling, blood analysis, blood pressure measurement, cardiac and nutritional work-up and ultrasound evaluation.
Work package 3: collection of placental tissue, membranes, umbilical cord tissue and cord blood at time of delivery for basic research analysis. Evaluation of different molecular pathways and expressed genes between no PE, EOPE and LOPE and this in specific relation to the different high-risk groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment | – | Procedure: endometrium biopsy, Diagnostic Test: Transabdominal ultrasound, Diagnostic Test: Peripheral phlebotomy, Diagnostic Test: Urine collection, Other: MOCK frozen embryo transfer preparative cycle., Diagnostic Test: Baseline questionnaire, Other: collection of menstrual blood, Diagnostic Test: nutritional and metabolic work-up, Diagnostic Test: cardiac work-up, Diagnostic Test: Blood pressure measurementPeripheral blood collection. MOCK frozen embryo preparative cycle. Endometrial pipelle biopsy. Collection of menstrual blood. Questionnaire. Nutritional/metabolic evaluation. Cardiac work-up. Preconceptional and prenatal ultrasound. Blood pressure measurements. Urine analysis. |
| Oocyte acceptors | – | Procedure: endometrium biopsy, Diagnostic Test: Transabdominal ultrasound, Diagnostic Test: Peripheral phlebotomy, Diagnostic Test: Urine collection, Other: MOCK frozen embryo transfer preparative cycle., Diagnostic Test: Baseline questionnaire, Other: collection of menstrual blood, Diagnostic Test: nutritional and metabolic work-up, Diagnostic Test: cardiac work-up, Diagnostic Test: Blood pressure measurementPeripheral blood collection. MOCK frozen embryo preparative cycle. Endometrial pipelle biopsy. Collection of menstrual blood. Questionnaire. Nutritional/metabolic evaluation. Cardiac work-up. Preconceptional and prenatal ultrasound. Blood pressure measurements. Urine analysis. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients at high-risk of developing PE and planned to undergo ART: * Oocyte recipients: patients are planned to undergo a transfer of an embryo conceived with a donor oocyte * PCOS patients: patients diagnosed with polycystic ovary syndrome (Rotterdam criteria) and planned to undergo a IVF/ICSI or IVM treatment
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (24 listed)
- Known essential hypertension or development of a new-onset hypertension before 20 weeks' gestation
- Known diabetes type 1 or 2 before pregnancy
- Thyroid dysfunction not under control with medication:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endometrium biopsyThe 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. | Procedure or surgery | Oocyte acceptors, Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment |
| Transabdominal ultrasoundEvaluation of fetal biometry and doppler flow study using ultrasound. | Diagnostic test | Oocyte acceptors, Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment |
| Peripheral phlebotomysingle puncture collection of peripheral venous blood. | Diagnostic test | Oocyte acceptors, Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment |
| Urine collectionCollection of urine in a plastic cup. | Diagnostic test | Oocyte acceptors, Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment |
| 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. | Other | Oocyte acceptors, Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment |
| Baseline questionnairequestionnaire the patient has to fill in | Diagnostic test | Oocyte acceptors, Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment |
| collection of menstrual bloodcollection of menstrual blood during the first day of heavy menstrual flow for at least 6 hours | Other | Oocyte acceptors, Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment |
| nutritional and metabolic work-upIncluding body composition analysis by BIA/whole body MRI and analysis of resting energy expenditure (REE). | Diagnostic test | Oocyte acceptors, Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment |
| cardiac work-upUsing transthoracic ultrasound. | Diagnostic test | Oocyte acceptors, Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment |
| Blood pressure measurementBlood pressure measurement | Diagnostic test | Oocyte acceptors, Subfertile polycystic ovarian syndrome (PCOS) patients undergoing ART treatment |
Primary outcome
BMI (kg/m2)
Time frame: 1 year
measurement of height en weight. Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
Total energy expenditure (kcal/day)
Time frame: 1 year
Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
number of laps of 6MWT (number)
Time frame: 1 year
6 minute walking test Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
Saturation beginning and end of 6MWT (%)
Time frame: 1 year
6 minute walking test Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
pulse beginning and end of 6MWT
Time frame: 1 year
6 minute walking test Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
Effective maximal handgrip strength (KPa)
Time frame: 1 year
Hangrip strenght Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
Time until 50% of effective handgrip strenght (s)
Time frame: 1 year
Hangrip strenght Work package 1: preconceptional, metabolic analysis Work package 2: during pregnancy, metabolic analysis
IVSd (mm)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
PWTd (mm)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
LVEDD (mm)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
IVSs (mm)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
PWTs (mm)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
LVESD (mm)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
LV mass (indexed) mg/m2
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
LVEF (visual, manual modified Simpson's biplane, auto-EF) (%)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
LV GLS (LV MW) (-%)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle and left ventricle systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
E-wave velocity (cm/s)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
A-wave velocity (cm/s)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Deceleration time (ms)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
E/A ratio
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Septal wall e' (cm/s)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Lateral wall e' (cm/s)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
E/e' ratio
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
Septal e'/lateral e' ratio
Time frame: 1 year
Transthoracic ultrasound Evaluation of left ventricle diastolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
LA AP diameters (mm)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left atrium Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
LAESVi (mL/M2)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left atrium Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
La strain (-%)
Time frame: 1 year
Transthoracic ultrasound Evaluation of left atrium Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
TAPSE (mm)
Time frame: 1 year
Transthoracic ultrasound Evaluation of right ventricle and RV systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
RV s' (cm)
Time frame: 1 year
Transthoracic ultrasound Evaluation of right ventricle and RV systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
RV GLS (RV MW) (-%)
Time frame: 1 year
Transthoracic ultrasound Evaluation of right ventricle and RV systolic function Work package 1: preconceptional, Work package 2: during pregnancy, cardiac evaluation
systolic, diastolic bloodpressure and mean arterial pressure (mmHg)
Time frame: 1 year
Blood pressure measurement device. Work package 1: preconception Work package 2: during pregnancy
Pulsatility index of the uterine artery
Time frame: 1 year
ultrasound Work package 1: preconception Work package 2: during pregnancy
(sub)endometrial flow (1,2,3)
Time frame: 1 year
ultrasound Work package 1: preconception Work package 2: during pregnancy
PRL mRNA expression
Time frame: 3 months
RNA sequencing Work package 1: preconception
PRL production (ng/ml)
Time frame: 3 months
ELISA Work package 1: preconception
IGFBP1 mRNA expression
Time frame: 3 months
RNA sequencing Endometrial tissue Work package 1: preconception
IGFBP1 (pg/ml)
Time frame: 3 months
ELISA Endometrial tissue Work package 1: preconception
PlGF (pg/ml)
Time frame: 3 months
blood sample Work package 1: preconception Work package 2: during pregnancy
sFLT1 (pg/ml)
Time frame: 3 months
blood sample Work package 1: preconception Work package 2: during pregnancy
sENG (ng/ml)
Time frame: 3 months
blood sample Work package 1: preconception Work package 2: during pregnancy
Incidence of positive PE screening (%)
Time frame: 6 months
Fetal medicine foundation screening algorithm. Work package 2: during pregnancy
Estimated fetal weight (g)
Time frame: 1 year
ultrasound Work package 2: during pregnancy
PI umbilical artery
Time frame: 1 year
ultrasound Work package 2: during pregnancy
PI uterine artery
Time frame: 1 year
ultrasound Work package 2: during pregnancy
gestational age at diagnoses PE (weeks)
Time frame: 1 year
work package 2: during pregnancy
incidence of PE (%)
Time frame: 1 year
work package 2: during pregnancy
severity of PE (mild/severe)
Time frame: 1 year
work package 2: during pregnancy
gestational age at delivery (weeks)
Time frame: 1 year
work package 3: at delivery
birth weight (grams)
Time frame: 1 year
work package 3: at delivery
APGAR scores of baby after 1, 5 and 10 minutes (1-10)
Time frame: 1 year
work package 3: at delivery
different expressed genes (DEGs) of placenta's
Time frame: 1 year
work package 3: at delivery RNA sequencing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shari Mackens, PhD, MD principal investigator
Medical director Brussels IVF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by CRG UZ Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study nurses Brussels IVF (+32 2 477 66 99, studieverpleegkundigen_crg@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (kg/m2) (time frame: 1 year). The study lists 51 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.