The maternal-embryo interaction and its role in the etiology of recurrent miscarriages

The maternal-embryo interaction and its role in the etiology of recurrent miscarriages - Maternal-embryo interaction in recurrent miscarriages

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36623

Enrollment

322

Registered

2010-02-09

Start date

2010-11-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

recurrent miscarriages recurrent pregnancy failure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Women with unexplained recurrent miscarriages (three or more first trimester miscarriages). 2. Proven fertile women (at least 1 successful pregnancy and no more than 1 miscarriage). 3. Age 18 - 40 years. 4. Willing and able to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Any identifiable causes of recurrent miscarriages; antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]), other recognised thrombophilic conditions (testing according to usual clinic practice), intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram or hysteroscopy), submucous fibroids and tests initiated only if clinically indicated such as tests for diabetes, thyroid disease and SLE 2. Undergoing treatment (hormonal) 3. Women using oral contraception or having an intra uterine device.

Design outcomes

Primary

Measure	Time frame
A) Embryo survival (indirect measure of embryo invasiveness) on decidualized ESCs of RM patients or fertile controls, and B) the angiogeneic VEGF production of dNK cells.	—

Secondary

Measure	Time frame
A) Embryo invasiveness and decidual acceptance 1. Embryo invasiveness: - Three embryo invasion characteristics (time to start invasion, depth of invasion, increase in embryo volume). - The chromosomal composition of the embryo. 2. Decidual acceptance - Decidualization (transcription factors, decidualization specific secretes and their mRNA). o Difference between cultures of dESCs of arrested vs. well developing embryos o Associated with invasiveness - ESC migration towards the embryo. B) Immune regulation - NK cell phenotype (CD3, CD16, CD56, granzyme-B and perforin expresson) and function (cytotoxicity, cytokines for angionenesis and trophoblast invasion) into more detail. - Immune regulatory capacity of ESCs.	—

Measure

Time frame

A) Embryo invasiveness and decidual acceptance 1. Embryo invasiveness: - Three embryo invasion characteristics (time to start invasion, depth of invasion, increase in embryo volume). - The chromosomal composition of the embryo. 2. Decidual acceptance - Decidualization (transcription factors, decidualization specific secretes and their mRNA). o Difference between cultures of dESCs of arrested vs. well developing embryos o Associated with invasiveness - ESC migration towards the embryo. B) Immune regulation - NK cell phenotype (CD3, CD16, CD56, granzyme-B and perforin expresson) and function (cytotoxicity, cytokines for angionenesis and trophoblast invasion) into more detail. - Immune regulatory capacity of ESCs.

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Countries

Netherlands

Outcome results