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DONation of Oocytes in Reproduction (DONOR); clinical and immunological aspects of oocyte donation pregnancies

DONation of Oocytes in Reproduction (DONOR); clinical and immunological aspects of oocyte donation pregnancies - DONOR study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54498
Enrollment
541
Registered
2016-02-16
Start date
2016-09-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia pregnancy toxicosis

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Subjects that are mentally or legally incapable or with known chromosomal abnormalities (e.g. Turner XO syndrome) will be excluded.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Contacts

Public ContactMLP van der Hoorn

Leids Universitair Medisch Centrum

m.l.p.van_der_hoorn@lumc.nl071 526 2896

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)