NCT06322498

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

July 10, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 18, 2023

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

July 10, 2022

Last Update Submit

March 20, 2024

Conditions

Infertility Due to NonimplantationInfertility SecondaryCesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • Inflammatory cell population

    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

Study Arms (2)

Intact uterus

EXPERIMENTAL

Patients with intact uterus

Diagnostic Test: Uterine lavage

Scarred uterus

EXPERIMENTAL

Patients with scarred uterus

Diagnostic Test: Uterine lavage

Interventions

Uterine lavageDIAGNOSTIC_TEST

Infusion of 2ml 0.9%NACL into the uterine cavity and aspiration of the fluid

Intact uterusScarred uterus

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Patients suffering from infertility and assigned for a hydrosonography exam for assessment of the integrity of the uterus and fallopian tubes.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Central Study Contacts

Chana Adler, MD

CONTACT

972-50-8779068chanaa@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, IVF clinic physician

Study Record Dates

First Submitted

July 10, 2022

First Posted

March 21, 2024

Study Start

January 18, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations

IL(1)