EndometriosisNCT04091997
Macrophage Migration Inhibitory Factor for Diagnosing Endometriosis and Its Severity
An observational study of Endometriosis, run by Fayoum University Hospital.
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… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- serum Eliza assay
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2018
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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.
Who cannot join
- Women with bleeding tendency,
- suspicious of gynecologic malignancy or
- active infection
About this study
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
Read the 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.
- Conditions
- Endometriosis
- Being tested
- serum Eliza assay
- Keywords
- Macrophage migration inhibitory factor, Endometriosis, Laparoscopy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum Eliza assayDiagnostic test
Also called laparoscopy
laparoscopy and biopsy of lesions in endometriotic patients and seum ELIZA assay of microphage migration inhibitory factor
| Study group | Role | What they receive |
|---|---|---|
| endometriosis | laparoscopy and directed biopsy of lesions serum macrophage migration inhibitory factor ELIZA assay Receives: Diagnostic Test: serum Eliza assay | |
| control | diagnostic laparoscopy serum macrophage migration inhibitory factor ELIZA assay Receives: Diagnostic Test: serum Eliza assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study startMar 2016
- Primary completionSep 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar MY Elbaradie, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091997
- Sponsor's protocol ID
- fayoum UH
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macrophage Migration Inhibitory Factor for Diagnosing Endometriosis and Its Severity
- ClinicalTrials.gov ID
- NCT04091997
- Acronym / sponsor ID
- fayoum UH
- Conditions
- Endometriosis
- Keywords
- Macrophage migration inhibitory factor, Endometriosis, Laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endometriosis | – | Diagnostic Test: serum Eliza assaylaparoscopy and directed biopsy of lesions serum macrophage migration inhibitory factor ELIZA assay |
| control | – | Diagnostic Test: serum Eliza assaydiagnostic laparoscopy serum macrophage migration inhibitory factor ELIZA assay |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Women with bleeding tendency,
- suspicious of gynecologic malignancy or
- active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum Eliza assayAlso: laparoscopylaparoscopy and biopsy of lesions in endometriotic patients and seum ELIZA assay of microphage migration inhibitory factor | Diagnostic test | control, endometriosis |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Fayoum University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of serum macrophage migration inhibitory factor and stage of the disease (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.