- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06322498
Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity
March 20, 2024 updated by: Chana Adler, Hadassah Medical Organization
A prospective study that will take place in the hydrosonography clinic, comparing patients with an intact uterus to those who had a caesarean section.
Eligible patients will preform a transvaginal ultrasound for evaluation of presence of a niche.
After fixation of the transcervical catheter, we will flush 2 ml sterile NaCl 0.9% into the uterine cavity and aspirate the fluid.
After collecting all samples, the samples will be snap frozen and stored at -80o C, until they undergo an immunological analysis.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chana Adler, MD
- Phone Number: 972-50-8779068
- Email: chanaa@hadassah.org.il
Study Locations
-
-
-
Jerusalem, Israel
- Recruiting
- Hadassah Medical Organization
-
Principal Investigator:
- Chana Adler Lazarovits, MD
-
Contact:
- Hadas Lemberg, PhD
- Phone Number: 00 972 2 6777572
- Email: lhadas@hadassah.org.il
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients suffering from infertility and assigned for a hydrosonography exam for assessment of the integrity of the uterus and fallopian tubes.
Exclusion Criteria:
- Patients with hydrosalpinx/pyosalpinx/sactosalpinx
- Patients who went through surgical correction of a niche
- Hormonal treatment- estrogens or progestins.
- Immunosuppressive/immunomodulating medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intact uterus
Patients with intact uterus
|
Infusion of 2ml 0.9%NACL into the uterine cavity and aspiration of the fluid
|
Experimental: Scarred uterus
Patients with scarred uterus
|
Infusion of 2ml 0.9%NACL into the uterine cavity and aspiration of the fluid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory cell population
Time Frame: Through study completion, an average of 1 year
|
The wash samples are processed, supernatant discarded and RBCs removed.
Cells are then washed with FACS buffer ,subjected to antibody staining and examined by flow cytometry.
Antibodies include: CD45,UV,CD3,CD19,CD66B,CD88, CD89, CD14,CD16,CD314,HLA-DR in order to identify monocytes, dendritic cells, T cells, B cells, NK and Neutrophil populations
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
July 10, 2022
First Submitted That Met QC Criteria
March 20, 2024
First Posted (Actual)
March 21, 2024
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INFLAM.UTERUS-HMO-CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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