Analyzing the microbiome in women with endometriosis and unexplained infertility
"Is the Reduced Quality of Life of Women With Endometriosis the Result of Peritoneal Dysbiosis?"
NA · Jagiellonian University · NCT05824819
This study is testing how the gut and other microbiomes in women with endometriosis or unexplained infertility might be linked to their symptoms and quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Jagiellonian University (other) |
| Locations | 1 site (Krakow) |
| Trial ID | NCT05824819 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the gut, peritoneal, and uterine microbiomes in women undergoing laparoscopy for endometriosis or idiopathic infertility. It will analyze the correlation between microbiome composition and the severity of endometriosis, as well as the relationship between microbiome profiles and symptoms such as pain and infertility. Additionally, the study will assess the quality of life in participants using the SF-36 questionnaire, comparing results between the two groups. The methodology involves Next Generation Sequencing (NGS) to provide detailed insights into the microbiome's role in these conditions.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 who require surgical treatment for endometriosis or have idiopathic infertility.
Not a fit: Patients with recent abdominal surgeries, active genital infections, inflammatory bowel disease, or those on antibiotics or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of endometriosis and unexplained infertility, potentially enhancing treatment options.
How similar studies have performed: While the investigation of the microbiome in relation to endometriosis is a growing field, this specific approach combining multiple microbiome analyses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18-45 years * indications for surgical treatment of endometriosis by laparoscopy and/or indications for invasive diagnostics by laparoscopy due to idiopathic infertility. Exclusion Criteria: * abdominal surgeries performed within 6 months prior hospitalisation * active infection of the genital tract * inflammatory bowel disease * antibiotic therapy and use of probiotics within 3 months before surgery
Where this trial is running
Krakow
- Jagiellonian University Medical College, Department of Gynecology and Obstetrics — Krakow, Poland (RECRUITING)
Study contacts
- Study coordinator: Iwona M. Gawron, Ph.D.
- Email: iwona.gawron@uj.edu.pl
- Phone: +48 124248571
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.
Conditions: Endometriosis, Infertility Unexplained