Infertility UnexplainedNCT05680350
Relation Between MicroRNA 203 and 210 and Sparing the Laparoscopic Examination in Cases of Unexplained Infertility
A study testing Laparoscopic Exploration and Estimation of Plasma Expression level of MICRO RNA 203 & 210 in people with Infertility Unexplained and Endometriosis, run by Benha University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- Infertility Unexplained, Endometriosis
- What is being tested?
- Laparoscopic Exploration and Estimation of Plasma Expression level of MICRO RNA 203 & 210
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Nov 2020to 25 Mar 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 30 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 30-45 years old
- Unexplained infertility
Who cannot join
- Presence of other causes of infertility,
- age out of the predetermined range,
- the presence of immune disorders,
- maintenance on immunosuppressive drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma Levels of Micro RNA 203 and 210 Might Spare the Exploratory Laparoscopy in Case of un Explained Infertility With Suspected Endometriosis
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.
- Conditions
- Infertility Unexplained, Endometriosis
- Being tested
- Laparoscopic Exploration, Estimation of Plasma Expression level of MICRO RNA 203 & 210
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ExplorationProcedure or surgery
Laparoscopic Exploration to diagnose \& grade endometriosis
Estimation of Plasma Expression level of MICRO RNA 203 & 210Diagnostic test
estimation of Plasma Expression level for Gene"Micro RNA "203 \& 210" by qRT-PCR
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Study group Patients with unexplained infertility had estimated their Plasma Expression level for Gene"Micro RNA "203 \& 210" by qRT-PCR followed by laparoscopic exploration Receives: Procedure: Laparoscopic Exploration; Diagnostic Test: Estimation of Plasma Expression level of MICRO RNA 203 & 210 |
| Control Group | Active comparator | Control group Patients with unexplained infertility underwent laparoscopy only Receives: Procedure: Laparoscopic Exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
grading of endometriosis
The diagnostic performance of estimated plasma levels of microRNA for diagnosis and grading endometriosis
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start7 Nov 2020
- Primary completion12 Nov 2021
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility UnexplainedStudies of the same condition, open and under way.
- More trials run by Benha 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Sharaf Eldein, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680350
- Sponsor's protocol ID
- RC 2.6.2022
- Status last verified
- Dec 2022
- First submitted
- 26 Dec 2022
- Last updated
- 11 Jan 2023
- 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 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Levels of Micro RNA 203 and 210 Might Spare the Exploratory Laparoscopy in Case of un Explained Infertility With Suspected Endometriosis
- ClinicalTrials.gov ID
- NCT05680350
- Acronym / sponsor ID
- RC 2.6.2022
- Conditions
- Infertility Unexplained, Endometriosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 7 Nov 2020 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 11 Jan 2023 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Procedure: Laparoscopic Exploration, Diagnostic Test: Estimation of Plasma Expression level of MICRO RNA 203 & 210Study 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 comparator | Procedure: Laparoscopic ExplorationControl group Patients with unexplained infertility underwent laparoscopy only |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 30-45 years old
- Unexplained infertility
Key exclusion criteria (4 listed)
- Presence of other causes of infertility,
- age out of the predetermined range,
- the presence of immune disorders,
- maintenance on immunosuppressive drugs
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 ExplorationLaparoscopic Exploration to diagnose \& grade endometriosis | Procedure or surgery | Control Group, Study group |
| Estimation of Plasma Expression level of MICRO RNA 203 & 210estimation of Plasma Expression level for Gene"Micro RNA "203 \& 210" by qRT-PCR | Diagnostic test | Study group |
Primary outcome
grading of endometriosis
Time frame: 8 months
The diagnostic performance of estimated plasma levels of microRNA for diagnosis and grading 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 11 Jan 2023.
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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 Exploration and Estimation of Plasma Expression level of MICRO RNA 203 & 210 in people with Infertility Unexplained and Endometriosis, run by Benha 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 2 inclusion and 4 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 11 Jan 2023. 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?
grading of endometriosis (time frame: 8 months). 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 11 Jan 2023.