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

NCT ID: NCT06322498

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Infertility Due to Nonimplantation Infertility Secondary Cesarean Section Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intact uterus

Patients with intact uterus

Group Type EXPERIMENTAL

Uterine lavage

Intervention Type DIAGNOSTIC_TEST

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

Scarred uterus

Patients with scarred uterus

Group Type EXPERIMENTAL

Uterine lavage

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Uterine lavage

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Chana Adler

Principal Investigator, IVF clinic physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Chana Adler, MD

Role: CONTACT

972-50-8779068

Facility Contacts

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Hadas Lemberg, PhD

Role: primary

00 972 2 6777572

Other Identifiers

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INFLAM.UTERUS-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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