Macrophage Migration Inhibitory Factor for Diagnosing Endometriosis and Its Severity

Completed

• Conditions: Endometriosis
• Interventions: Diagnostic Test: serum Eliza assay

• Registration Number: NCT04091997
• Lead Sponsor: Fayoum University Hospital

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

Detailed Description

observational case-control study conducted in Fayoum University hospital from March 2016 till September 2018. Three hundred women candidate for diagnostic laparoscopy for either infertility or gynecologic chronic pelvic pain were included. The study group included patients with diagnostic criteria of endometriosis. The control group included other causes of infertility or pelvic pain.

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2017-09
• Study Completion: 2018-09
• Status Verified: 2019-09
• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-14
• Study First Posted: 2019-09-17
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
endometriosis	serum Eliza assay	laparoscopy and directed biopsy of lesions serum macrophage migration inhibitory factor ELIZA assay
control	serum Eliza assay	diagnostic laparoscopy serum macrophage migration inhibitory factor ELIZA assay

Primary Outcome Measures

Name	Time	Method
level of serum macrophage migration inhibitory factor and stage of the disease	one year	serum MIF is a promising marker for noninvasive diagnosis of severity of endometriosis