Comparing inflammation markers in uterine fluid from normal and scarred uterine cavities
Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity
This study is testing if there are differences in inflammation markers in the uterine fluid of women with normal uteri compared to those who have had cesarean sections to see how it might relate to infertility and complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT06322498 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the differences in inflammation markers present in fluid aspirated from the uterine cavities of women with intact uteri compared to those who have undergone cesarean sections. Patients will undergo a transvaginal ultrasound to assess uterine integrity, followed by a uterine lavage procedure where sterile saline will be introduced and fluid will be collected for analysis. The collected samples will be snap frozen for immunological analysis to identify potential markers associated with infertility due to nonimplantation and cesarean section complications.
Who should consider this trial
Good fit: Ideal candidates for this study are women experiencing infertility who are scheduled for a hydrosonography exam to evaluate their uterine and fallopian tube integrity.
Not a fit: Patients with conditions such as hydrosalpinx or those who have undergone surgical correction of a niche may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the underlying causes of infertility related to uterine scarring, potentially leading to improved treatment options.
How similar studies have performed: While this approach is relatively novel, similar studies investigating uterine inflammation and its impact on fertility have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jerusalem
- Hadassah Medical Organization — Jerusalem, Israel (Recruiting)
Study contacts
- Study coordinator: Chana Adler, MD
- Email: chanaa@hadassah.org.il
- Phone: 972-50-8779068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.