Relation Between MicroRNA 203 and 210 and Sparing the Laparoscopic Examination in Cases of Unexplained Infertility
Plasma Levels of Micro RNA 203 and 210 Might Spare the Exploratory Laparoscopy in Case of un Explained Infertility With Suspected Endometriosis
1 other identifier
interventional
100
1 country
1
Brief Summary
The study targets to evaluate the role of estimation of plasma expression levels of gene of microRNAs 203 and 210 in helping to diagnose and grade endometriosis. The study included women with unexplained infertility and clinical picture suggestive of presence of endometriosis were divided randomly into two groups: Control and study groups. All patients underwent exploratory laparotomy for diagnosis and grading of endometriosis if present. Patients of study group gave blood samples for estimation of plasma expression levels of microRNA 203 and 210 using qRT-PCR procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2022
CompletedFirst Submitted
Initial submission to the registry
December 26, 2022
CompletedFirst Posted
Study publicly available on registry
January 11, 2023
CompletedJanuary 11, 2023
December 1, 2022
1 year
December 26, 2022
January 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
grading of endometriosis
The diagnostic performance of estimated plasma levels of microRNA for diagnosis and grading endometriosis
8 months
Study Arms (2)
Study group
ACTIVE COMPARATORStudy group Patients with unexplained infertility had estimated their Plasma Expression level for Gene"Micro RNA "203 \& 210" by qRT-PCR followed by laparoscopic exploration
Control Group
ACTIVE COMPARATORControl group Patients with unexplained infertility underwent laparoscopy only
Interventions
Laparoscopic Exploration to diagnose \& grade endometriosis
estimation of Plasma Expression level for Gene"Micro RNA "203 \& 210" by qRT-PCR
Eligibility Criteria
You may qualify if:
- years old
- Unexplained infertility
You may not qualify if:
- Presence of other causes of infertility,
- age out of the predetermined range,
- the presence of immune disorders,
- maintenance on immunosuppressive drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Banha University
Banhā, El- Qalyobia, 13511, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of gynecology
Study Record Dates
First Submitted
December 26, 2022
First Posted
January 11, 2023
Study Start
November 7, 2020
Primary Completion
November 12, 2021
Study Completion
March 25, 2022
Last Updated
January 11, 2023
Record last verified: 2022-12