Macrophage Migration Inhibitory Factor for Diagnosing Endometriosis and Its Severity

September 17, 2019 updated by: Sahar MY Elbaradie, Fayoum University Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

300

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

19 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability 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

Description

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 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
endometriosis
laparoscopy and directed biopsy of lesions serum macrophage migration inhibitory factor ELIZA assay
laparoscopy and biopsy of lesions in endometriotic patients and seum ELIZA assay of microphage migration inhibitory factor
Other Names:
  • laparoscopy
control
diagnostic laparoscopy serum macrophage migration inhibitory factor ELIZA assay
laparoscopy and biopsy of lesions in endometriotic patients and seum ELIZA assay of microphage migration inhibitory factor
Other Names:
  • laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of serum macrophage migration inhibitory factor and stage of the disease
Time Frame: one year
serum MIF is a promising marker for noninvasive diagnosis of severity of endometriosis
one year

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)

March 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

September 14, 2019

First Posted (Actual)

September 17, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fayoum UH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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