The aim of the DONOR study is to define if OD pregnancies, specifically those with immunogenetic differences between mother and child, are associated with abnormal placentation and vasculogenesis, resulting in distinct maternal immunomodulation and…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical outcome (e.g. pregnancy complications, such as miscarriage and
preeclampsia) is studied in relation to the level of immunogenetic differences
between mother and child.
Secondary outcome
Several aspects of the innate and cellular immune response (such as complement
factors, cytokine profile and cell phenotyping) in respect to clinical outcome
and pregnancy complications.
Secondary study parameters, mainly relevant for this amendment include:
- The association of a high number of fetal-maternal HLA mismatches, and the
severity and time to development of pre-eclampsia in OD pregnancies.
- The association of age, parity, multiple gestation, ethnicity and other
factors on the development of preeclampsia in OD pregnancies.
- The prognostic effect of other factors (such as age, indication of OD, etc.),
including level of HLA mismatches, on the development of preeclampsia in OD
pregnancies.
- To develop a prediction model to predict development of hypertensive disease
during OD pregnancy.
Background summary
Oocyte donation (OD) is a specific method of assisted reproductive technology
that enables women with various causes of reproductive failure to conceive, but
is accompanied with a high risk for certain pregnancy disorders. Compared to
spontaneous and in vitro fertilization (IVF) pregnancies, OD pregnancies are
associated with a 30-50% higher risk for hypertensive complications. Possibly,
the immunogenetic differences between mother and fetus, expressed in HLA
mismatches, may play a role in the development of these complications.
Study objective
The aim of the DONOR study is to define if OD pregnancies, specifically those
with immunogenetic differences between mother and child, are associated with
abnormal placentation and vasculogenesis, resulting in distinct maternal
immunomodulation and specific pregnancy complications. With this amendment, we
seek permission to include retro- and prospective cohorts from UMCG, Isala, and
Nijgeertgen to increase inclusivity and population diversity, aiming to develop
the first predictive model for hypertensive complications in egg donation
pregnancies (secondary outcome measure). The estimated study end date remains
01-01-2026.
Study design
The project will be performed as a multicentre prospective and retrospective
cohort study.
Study burden and risks
No experimental medication will be used. Women will be treated according to
local hospital protocol. For the withdrawal of blood, hardly any serious
adverse events are to be expected. For the prospective cohort study, no
additional hospital visits are required. For the retrospective cohort study, an
additional hospital visit or at home visit will be necessary if women are
wanting to participate in the collection of their blood and saliva of their
child(ren). The web-based questionnaire is estimated to be a little burden, as
some questions may be confrontational.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Women who conceived through IVF/ICSI with donated oocytes or autologous
oocytes, women who conceived after embryo donation, women with surrogacy
pregnancy, and women with spontaneously conceived pregnancies.
Exclusion criteria
Subjects that are mentally or legally incapable or with known chromosomal
abnormalities (e.g. Turner XO syndrome) will be excluded.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56308.058.16 |