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

Recruiting

• Conditions: recurrent miscarriages; recurrent pregnancy failure; 10026908; 10013356; 10016214

• Registration Number: NL-OMON36623
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 322

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A) Embryo survival (indirect measure of embryo invasiveness) on decidualized<br /><br>ESCs of RM patients or fertile controls, and B) the angiogeneic VEGF production<br /><br>of dNK cells.</p><br>

Secondary Outcome Measures

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