Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity

Not Applicable

Recruiting

• Conditions: Infertility Secondary; Infertility Due to Nonimplantation; Cesarean Section Complications
• Interventions: Diagnostic Test: Uterine lavage

• Registration Number: NCT06322498
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-10
• Study Start: 2023-01-18
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

1. Patients with hydrosalpinx/pyosalpinx/sactosalpinx
2. Patients who went through surgical correction of a niche
3. Hormonal treatment- estrogens or progestins.
4. Immunosuppressive/immunomodulating medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intact uterus	Uterine lavage	Patients with intact uterus
Scarred uterus	Uterine lavage	Patients with scarred uterus

Primary Outcome Measures

Name	Time	Method
Inflammatory cell population	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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel