EndometriosisNCT05556213
The Relation Between MiR-125b-5p and Staging of Endometriosis
A study testing laparoscopic examination and Blood sampling in people with Endometriosis, run by Tanta University at 1 site in Egypt.
Trial summary
78 endometriosis patients presented with infertility were clinically examined and the diagnosis was assured by US imaging. The study also included 11 control fertile women free of gynecological problems as a control for lab tests. Patients and controls gave blood samples for lab investigations. Read more about this study
- Who is it for?
- Ages 22 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- laparoscopic examination and Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2020to 15 Jul 2022
- Phase
- Interventional
- 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 22 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who presented clinical pictures suggestive of EM disease
Who cannot join
- Patients with previous pelvic or abdominal surgery that may hinder the laparoscopic examination,
- patients who were suspicious of having malignancy elsewhere in the body region,
- pregnant women,
- patients who had diabetes mellitus,
- body mass index (BMI) of >30 kg/m2, coagulopathies, and autoimmune disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Plasma Levels of MicroRNA 125b-5p and Transvaginal Ultrasonography May Spare Laparoscopy for Staging of Endometriosis
78 endometriosis patients presented with infertility were clinically examined and the diagnosis was assured by US imaging. The study also included 11 control fertile women free of gynecological problems as a control for lab tests. Patients and controls gave blood samples for lab investigations. All patients underwent diagnostic abdominal laparoscopy under general anesthesia for disease staging. Quantitative determination of expression levels of genes of microRNA-125b-5p and 203a was conducted using qRT-PCR.
- Conditions
- Endometriosis
- Being tested
- laparoscopic examination, Blood sampling
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic examinationProcedure or surgery
laparoscopic examination for staging of endometriosis
Blood samplingDiagnostic test
Blood sample to detect endometriosis
| Study group | Role | What they receive |
|---|---|---|
| Patients | Active comparator | Not described Receives: Procedure: laparoscopic examination |
| Control | Active comparator | Not described Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of Plasma expression level
the diagnostic validity of estimation of plasma expression levels of MiR-125b-5p and 203a for diagnosis and staging of endometriosis.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start12 May 2020
- Primary completion11 Jan 2022
- Study completion15 Jul 2022
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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hagars, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556213
- Sponsor's protocol ID
- 35617/8/22
- Status last verified
- Sep 2022
- First submitted
- 24 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Plasma Levels of MicroRNA 125b-5p and Transvaginal Ultrasonography May Spare Laparoscopy for Staging of Endometriosis
- ClinicalTrials.gov ID
- NCT05556213
- Acronym / sponsor ID
- 35617/8/22
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 27 Sep 2022 (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.
78 endometriosis patients presented with infertility were clinically examined and the diagnosis was assured by US imaging. The study also included 11 control fertile women free of gynecological problems as a control for lab tests. Patients and controls gave blood samples for lab investigations. All patients underwent diagnostic abdominal laparoscopy under general anesthesia for disease staging. Quantitative determination of expression levels of genes of microRNA-125b-5p and 203a was conducted using qRT-PCR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Active comparator | Procedure: laparoscopic examination |
| Control | Active comparator | Diagnostic Test: Blood sampling |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who presented clinical pictures suggestive of EM disease
Key exclusion criteria (5 listed)
- Patients with previous pelvic or abdominal surgery that may hinder the laparoscopic examination,
- patients who were suspicious of having malignancy elsewhere in the body region,
- pregnant women,
- patients who had diabetes mellitus,
- body mass index (BMI) of >30 kg/m2, coagulopathies, and autoimmune disorders.
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 |
|---|---|---|
| laparoscopic examinationlaparoscopic examination for staging of endometriosis | Procedure or surgery | Patients |
| Blood samplingBlood sample to detect endometriosis | Diagnostic test | Control |
Primary outcome
Validity of Plasma expression level
Time frame: two weeks
the diagnostic validity of estimation of plasma expression levels of MiR-125b-5p and 203a for diagnosis and staging 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 27 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic examination and Blood sampling in people with Endometriosis, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 5 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 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Validity of Plasma expression level (time frame: two weeks). 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 27 Sep 2022.