Mucosal-Associated Invariant T Cells in Cases of Miscarriage

January 30, 2023 updated by: Ahmed Mohamed Abbas, Assiut University

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Cairo
      • Assiut, Cairo, Egypt, 002
        • Ahmed Abbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All pregnant women presented with spontaneous miscarriage

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group
women with spontaneous miscarriage
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.

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
All markers will be measured by flow cytometry
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2021

Primary Completion (ACTUAL)

October 1, 2022

Study Completion (ACTUAL)

December 1, 2022

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (ACTUAL)

July 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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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