NCT04091997

Brief Summary

Endometriosis is a chronic disease affecting women of reproductive age. Macrophage migration inhibitory factor (MIF) is one of non-invasive blood biomarker that was detected in sera of endometriotic patients.The aim of this study was to evaluate the value of serum macrophage migration inhibitory factor in diagnosing endometriosis in women with infertility and chronic pelvic pain and correlate its level with the stage of the disease. Three hundred patient candidate for diagnostic laparoscopy were included in a case-control observational study

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Status
completed

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

March 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

September 13, 2019

Last Update Submit

September 17, 2019

Conditions

Keywords

Macrophage migration inhibitory factorEndometriosisLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • level of serum macrophage migration inhibitory factor and stage of the disease

    serum MIF is a promising marker for noninvasive diagnosis of severity of endometriosis

    one year

Study Arms (2)

endometriosis

laparoscopy and directed biopsy of lesions serum macrophage migration inhibitory factor ELIZA assay

Diagnostic Test: serum Eliza assay

control

diagnostic laparoscopy serum macrophage migration inhibitory factor ELIZA assay

Diagnostic Test: serum Eliza assay

Interventions

serum Eliza assayDIAGNOSTIC_TEST

laparoscopy and biopsy of lesions in endometriotic patients and seum ELIZA assay of microphage migration inhibitory factor

Also known as: laparoscopy
controlendometriosis

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Both groups were comparable regarding the baseline characteristics. these included age, parity, Body mass index, symptoms, type of infertility and chronic pelvic pain

You may qualify if:

  • postmenstrual women
  • in childbearing period,
  • presenting with either gynecologic chronic pelvic pain (CPP) or infertility
  • indicated and fit for diagnostic laparoscopy.
  • All women must have no hormonal treatment for the last 3 months and.

You may not qualify if:

  • Women with bleeding tendency,
  • suspicious of gynecologic malignancy or
  • active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometriosis

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate Professor

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 17, 2019

Study Start

March 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

September 19, 2019

Record last verified: 2019-09