Mucosal-Associated Invariant T Cells in Cases of Miscarriage

NCT04492098 | Completed DMC

• 1 other identifier: MAIT-RPL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Miscarriage

Outcome Measures

Primary Outcomes (1)

• 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

  All markers will be measured by flow cytometry

  24 hours

Study Arms (1)

study group

women with spontaneous miscarriage

Diagnostic Test: MAIT cells

Interventions

MAIT cells DIAGNOSTIC_TEST

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.

study group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All pregnant women presented with spontaneous miscarriage

You may qualify if:

• Regular marital life with the same partner.
• Regularly menstruating before current pregnancy.
• Spontaneous conception.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: June 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

EG (1)