NCT03941470

Brief Summary

To assess natural killer cells frequency and activation in cases of unexplained recurrent abortion in comparison to fertile cases

  • 2\. . To study the expression of stimulatory receptors of natural killer cell.
  • 3-To study the expression of inhibitory receptors of natural killer cell.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

May 6, 2019

Last Update Submit

May 6, 2019

Conditions

Keywords

NK ;natural killer cells

Outcome Measures

Primary Outcomes (1)

  • asses the number of Natural killer cells

    flowcytometry

    15 month

Study Arms (2)

unexplained recurrent pregnancy loss

peripheral blood sample examined by flowcytometry

control fertile multipara

peripheral blood sample examined by flowcytometry

Eligibility Criteria

AgeUp to 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

We will recruit patients from outpatient clinics from Assuit University Hospital,Women fulfilling eligibility criteria will be included after careful gynecologycal examination,Those who consent to participate will be referred to the lab for investigation.

You may qualify if:

  • Age less than 40 years. 2.History of two or more spontaneous miscarriages .

You may not qualify if:

  • \. Age more than 35 years. 2. Women with elevated level of TSH above (2.5 mIU/ml) or prolactin above( 19.5 ng/mL)and uncontrolled DM.
  • \. Women with autoimmune disorder (antiphospholipid antibody syndrome)with LA1/LA2 ratio more than( 1.2).
  • Women receiving oral contraceptive pills.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yossra Mahmoud Mohammed

Asyut, 088, Egypt

Location

Related Publications (1)

  • Fukui A, Kamoi M, Funamizu A, Fuchinoue K, Chiba H, Yokota M, Fukuhara R, Mizunuma H. NK cell abnormality and its treatment in women with reproductive failures such as recurrent pregnancy loss, implantation failures, preeclampsia, and pelvic endometriosis. Reprod Med Biol. 2015 Apr 11;14(4):151-157. doi: 10.1007/s12522-015-0207-7. eCollection 2015 Oct.

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • assiut university

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assesment of Natu

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 8, 2019

Study Start

April 30, 2019

Primary Completion

December 1, 2019

Study Completion

July 20, 2020

Last Updated

May 8, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol (IRB17200056)Access

Locations