- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04492098
Mucosal-Associated Invariant T Cells in Cases of Miscarriage
Analysis of Mucosal-Associated Invariant T (MAIT) Cells in Cases of Spontaneous and Recurrent Miscarriage
Miscarriage is the most frequently encountered complication of pregnancy ranging from 10% to 30%. The etiology of recurrent spontaneous miscarriage (RSM) in 40%-50% of cases cannot be identified. Immunological disturbances have been suggested to play an important role.
Previous studies have focused that women with miscarriage have elevated NK cell numbers and activity both in the periphery and in the endometrium. Also, NK cells in women with RSM displayed an imbalance of Killer cell Ig-like receptors (KIRs) in favor of activating KIR leading to an unbalanced activation of dNK cytotoxicity and higher risk of miscarriage.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo
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Assiut, Cairo, Egypt, 002
- Ahmed Abbas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Regular marital life with the same partner.
- Regularly menstruating before current pregnancy.
- Spontaneous conception.
Exclusion Criteria:
- Women with Polycystic ovarian syndrome or any endocrinal abnormalities like DM, thyroid disorders.
- History of abnormal uterine cavity proved by sonohysterography or hysteroscopy before pregnancy.
- Women with positive consanguinity.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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study group
women with spontaneous miscarriage
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1- Decidual tissues will be washed in phosphate buffer saline (PBS), and then preserved in Rosewell Park Memorial Institute (RPMI) 1640 medium supplemented with 100 U/mL penicillin, 100 mg/mL streptomycin and 5% fetal bovine serum (GIBCO BRL, Thermo Fisher Scientific, USA) until transfer to the laboratory.
At the flow cytometry laboratory, the tissue samples will be minced finely and enzymatically digested by adding 3 ml collagenase enzyme type Ia and 2 ml PBS for 40 minutes at 37°C in shaking water path at 100 r.p.m.
Cell suspensions obtained will be filtered, then the pellet after centrifugation will be treated with red blood cells lysing solution and washed with PBS.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentages of MAIT cells and MAIT cells expressing CD56 and CD16 in comparison with NK cells and NKT cells in both blood and decidua
Time Frame: 24 hours
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All markers will be measured by flow cytometry
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24 hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAIT-RPL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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