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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04091997
Other study ID # fayoum UH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2016
Est. completion date September 2018

Study information

Verified date September 2019
Source Fayoum University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date September 2018
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
serum Eliza assay
laparoscopy and biopsy of lesions in endometriotic patients and seum ELIZA assay of microphage migration inhibitory factor

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fayoum University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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