Actively Recruiting
A Study on the Correlation Between Endometriosis and Intra-tissue Microbiota
Led by Zhujiang Hospital · Updated on 2024-02-20
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Endometriosis is a common gynecological disease affecting women of reproductive age, causing pain, masses, and infertility. The exact cause of endometriosis is unclear. Researchers are examining the relationship between endometriosis and the microbiota found within tissue to better understand this condition. This observational study compares women diagnosed with endometriosis to those without it, often having other benign gynecologic conditions like uterine fibroids or teratomas. Participants will have samples collected before surgery, including blood serum, vaginal swabs, cervical mucus, and feces. During surgery, if possible, additional samples such as peritoneal fluid and both eutopic and ectopic endometrial tissue will be taken. These samples will undergo various sequencing methods like microbiota, transcriptome, metabolome, and single-cell sequencing to analyze microbial composition and related mechanisms. During the study, participants will be evaluated through surgical confirmation and biopsy analysis. Researchers will measure the composition of intra-tissue microbiota using metagenomics next-generation sequencing over a three-year period. The study includes detailed sample collection and laboratory experiments to explore the microbiota's role in endometriosis, with participation lasting from screening through surgical and laboratory procedures.
CONDITIONS
Brief Title
A Study on the Correlation Between Endometriosis and Intra-tissue Microbiota
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 52 years old
- Regular menstrual cycles lasting 28 to 35 days
- No sexual intercourse for at least one week before surgery
- No systemic or local use of antibiotics or probiotics in the six months prior to surgery
- No history of acute or chronic pelvic inflammatory disease
- Ability to understand the study and provide informed consent
You will not qualify if you...
- Currently pregnant
- Presence of malignant or junctional disease found during surgery or pathology
- Severe pelvic anatomical abnormalities
- Pelvic contamination with large amounts of blood during laparoscopic surgery
- History of gene therapy, blood transfusion, stem cell therapy, or bone marrow transplantation
- Psychiatric or personality disorders, or abuse of psychoactive substances
- Immunodeficiency, allergies, or autoimmune diseases
- Contraindications to endotracheal intubation anesthesia
- Absolute or relative contraindications to laparoscopic or hysteroscopic surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo laparoscopic surgery and biopsy to confirm the presence or absence of endometriosis and collect tissue and fluid samples for microbiota analysis.
1 surgical visit (in-person)
Duration - Up to 3 years
Participants' tissue samples are analyzed over time to study the intra-tissue microbiota composition related to endometriosis.
Trial Site Locations
Total: 1 location
1
Zhujiang Hospital
Guangzhou, Guangdong, China, 510280
Actively Recruiting
Research Team
Z
Ziwei Zhou, Dr
Y
Yuying Chen, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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