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CompletedNCT05556213Updated Sep 27, 2022

The Relation Between MiR-125b-5p and Staging of Endometriosis

An interventional study of laparoscopic examination and Blood sampling in Endometriosis, sponsored by Tanta University. Completed at 1 site in Egypt. Open to female participants aged 22 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-27.

Sponsored by Tanta University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled May 2020, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
89
Allocation
Non-randomized
Ages
22 Years to 45 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Endometriosis

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03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 89 is above the median of 64 across 525 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients who presented clinical pictures suggestive of EM disease

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
89 participants (actual)

Study arms

  • Active comparator
    Patients

    Procedure: laparoscopic examination

  • Active comparator
    Control

    Diagnostic Test: Blood sampling

Interventions

  • Procedurelaparoscopic examination

    laparoscopic examination for staging of endometriosis

  • Diagnostic testBlood sampling

    Blood sample to detect endometriosis

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: two weeks

07

Study locations

1 site
  • Tanta university
    Tanta, El-Gharbyia 13511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05556213
Lead sponsor
Tanta University
Responsible party
Ahmed Hagars (Assistant professor of gynecology, Tanta University) — Principal investigator
First posted
Sep 27, 2022
Start date
May 12, 2020
Primary completion
Jan 11, 2022
Completion
Jul 15, 2022
Last update
Sep 27, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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