- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04091997
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:
|
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:
|
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.
Sponsor
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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