Is there a difference in morphological and vascular placental development between ART and naturally conceived pregnancies?
ID
Source
Brief title
Condition
- Other condition
- Placental, amniotic and cavity disorders (excl haemorrhages)
Synonym
Health condition
subfertiliteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are morphological placental characteristics such as placental
calcifications, placental lakes and placental location, and vascular placental
characteristics such as vascularisation index.
Secondary outcome
Secondary endpoints are placenta biomarkers such as β-hCG, PAPP-A, PlGF and
sFlt-1, foetal development, cell-free fetal DNA fraction in maternal plasma in
NIPT and neonatal outcomes.
Background summary
Pregnancies after assisted reproductive technology (ART) are more at risk for
adverse perinatal outcomes, such as pre-eclampsia and (very) low birthweight
compared to pregnancies after natural conception. The aetiology behind this
problem is not known, but there is evidence that the placenta plays an
important role in mediating the effects of ART on adverse pregnancy outcomes.
We therefore hypothesize that placental characteristics are different in
ART-pregnancies compared to naturally conceived pregnancies. The Pulse-IVF
study will focus on placental development in the first 20 weeks of gestation
and will compare ART-pregnancies and naturally conceived pregnancies.
Study objective
Is there a difference in morphological and vascular placental development
between ART and naturally conceived pregnancies?
Study design
This is a prospective cohort study, in which the placenta and foetus of
pregnant women will be investigated by ultrasound and Doppler at 5 times during
pregnancy: at 8, 10, 12, 16 and 20 weeks of gestation. At 8, 12 and 20 weeks of
pregnancy, blood will be drawn for the determination of placenta biomarkers.
Participants are asked for permission to collect the results of the
non-invasive prenatal test (NIPT) including the cell-free fetal DNA fraction
(if applicable). At the end of pregnancy a delivery report will be requested
from the midwife or gynecologist to obtain information on pregnancy outcomes
such as birthweight, gestational age at delivery, maternal and neonatal
complications.
Study burden and risks
Subjects will visit the hospital 5 times during pregnancy for an ultrasound and
blood withdrawal (only on 3 time points). This might be experienced as a
burden, however all appointments will be scheduled in consultation with each
subject and will be combined with regular appointments as much as possible.
There are no risks for participating in this study.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Maternal age >= 18 years
- Singleton pregnancy
- Naturally conceived or conceived after IVF or ICSI with or without
pre-implantation genetic testing (PGT)
- Good understanding of the Dutch language
- BMI <= 35 kg/m2
Exclusion criteria
- Pregnant via other ART-treatments such as ovulation induction (OI),
intra-uterine insemination (IUI) or controlled ovarian hyperstimulation (COH)
only.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71273.068.19 |
| Other | NL7973 |
| OMON | NL-OMON22332 |