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

Hadassah Medical Center

Status: Enrolling

Conditions: Infertility Due to Nonimplantation; Cesarean Section Complications; Infertility Secondary

Treatments: Diagnostic Test: Uterine lavage

Study type: Interventional

Funder types: Other

Identifiers

NCT06322498

INFLAM.UTERUS-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intact uterus

Experimental group

Description:

Patients with intact uterus

Treatment:

Diagnostic Test: Uterine lavage

Scarred uterus

Experimental group

Description:

Patients with scarred uterus

Treatment:

Diagnostic Test: Uterine lavage