A Study on the Correlation Between Endometriosis and Intra-tissue Microbiota

NCT06266897 | Recruiting

• 1 other identifier: ZhujiangEM
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis (EM) is a common gynecological condition, but the pathogenesis of it has not yet been clarified. Here, the investigators wanted to investigate the correlation between endometriosis and the intra-tissue microbiota. The investigators planed to collect serum, vaginal swabs, cervical mucus, feces, peritoneal fluid, and endometrial tissue for sequencing and experiments.

Conditions

Endometriosis

Keywords

Microbiota; Microbiome; Endometriosis

Outcome Measures

Primary Outcomes (1)

• Metagenomics Next Generation Sequencing of the Intra-tissue Microbiota Composition

  Using metagenomics sequencing of microbiota, compare the microbial composition differences of specimens derived from EM group and control group, including the alpha diversity(Shannon index, Simpson index, etc.), beta diversity(PCoA analysis, Bray-Curtis, etc.) differential taxonomy, and KEGG pathway prediction.

  3 years

Study Arms (2)

EM group

Patient diagnosed with endometriosis after confirmation by laparoscopic surgery and pathologic examination.

Control group

Patient diagnosed without endometriosis after confirmation by laparoscopic surgery and pathologic examination, usually with benign gynecologic conditions such as uterine fibroids or teratomas.

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants in this study will be recruited in the obstetrics and Obstetrics and Gynecology Medical Center of Zhujiang Hospital. With reference to the inclusion and exclusion criteria, patients admitted for surgery were under screening.

You may qualify if:

• Women aged 18-52 years old.
• Regular menstruation with a cycle of 28-35 days.
• No sexual intercourse 1 week before the operation.
• No systemic or local use of antibiotics and probiotics for 6 months prior to surgery.
• No history of acute or chronic pelvic inflammatory disease.
• Subjects fully understand the significance of the study and sign the informed consent form.

You may not qualify if:

• In pregnancy.
• Intraoperative conditions or pathological examination suggest a malignant or junctional disease.
• Severe anatomical abnormalities of the pelvis.
• Pelvic contamination with large amounts of blood during laparoscopic operation.
• History of gene therapy, blood transfusion, stem cell therapy, or bone marrow transplantation
• Psychiatric, personality disorders, or abuse of psychoactive substances.
• Immunodeficiencies, allergies, or autoimmune diseases.
• Contraindications to endotracheal intubation anesthesia.
• Absolute or relative contraindications to laparoscopic or hysteroscopic surgery.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, 510280, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will obtain serum, vaginal swabs, cervical mucus, and feces from the participant before surgery. We will also collect peritoneal fluid, eutopic endometrium, and ectopic endometrium lesion if the surgical approach allows.

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ying Ma, PhD

  Zhujiang Hospital, Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziwei Zhou, Dr

CONTACT

+8615626400134; vivienchow@qq.com

Yuying Chen, Dr

CONTACT

+8618218058905; 2265991412@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 20, 2024
• Study Start: June 18, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-01

Locations

CN (1)