Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Inflammatory cell population
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intact uterus
Patients with intact uterus
Intervention: Uterine lavage (Diagnostic Test)
Scarred uterus
Patients with scarred uterus
Intervention: Uterine lavage (Diagnostic Test)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Chana Adler
Principal Investigator, IVF clinic physician
Hadassah Medical Organization