Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06266897
Other study ID # ZhujiangEM
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 18, 2023
Est. completion date December 2026

Study information

Verified date January 2024
Source Zhujiang Hospital
Contact Ziwei Zhou, Dr
Phone +8615626400134
Email vivienchow@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Endometriosis (EM) is a common gynecological condition that occurs in women of reproductive age and is characterized by pain, masses, and infertility. EM is a tumor-like disease that is invasive, metastatic, recurrent, but the pathogenesis of EM has not yet been clarified. Advances in the study of intratumoral microbiota provided increasing evidence confirming the presence and mechanism of bacteria in tumor tissues. Therefore, the investigators wanted to investigate the correlation between endometriosis and its microbiota in the endometrial tissue. 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. Participants were assigned to Endometriosis group after confirmation by laparoscopy together with biopsy analysis, while the control group was identified as non-EM patients, usually with benign gynecologic conditions such as uterine fibroids or teratomas. The investigators will obtain serum, vaginal swabs, cervical mucus, and feces from the participant before surgery. The peritoneal fluid, eutopic endometrium, and ectopic endometrium lesion will also be collected if the surgical approach allows. The specimens will be sent for microbiota sequencing, transcriptome sequencing, metabolome sequencing, single cell sequencing, and laboratory experiments.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 52 Years
Eligibility Inclusion Criteria: 1. Women aged 18-52 years old. 2. Regular menstruation with a cycle of 28-35 days. 3. No sexual intercourse 1 week before the operation. 4. No systemic or local use of antibiotics and probiotics for 6 months prior to surgery. 5. No history of acute or chronic pelvic inflammatory disease. 6. Subjects fully understand the significance of the study and sign the informed consent form. Exclusion Criteria: 1. In pregnancy. 2. Intraoperative conditions or pathological examination suggest a malignant or junctional disease. 3. Severe anatomical abnormalities of the pelvis. 4. Pelvic contamination with large amounts of blood during laparoscopic operation. 5. History of gene therapy, blood transfusion, stem cell therapy, or bone marrow transplantation 6. Psychiatric, personality disorders, or abuse of psychoactive substances. 7. Immunodeficiencies, allergies, or autoimmune diseases. 8. Contraindications to endotracheal intubation anesthesia. 9. Absolute or relative contraindications to laparoscopic or hysteroscopic surgery.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhujiang Hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT01931670 - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain Phase 3
Recruiting NCT05648669 - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain Phase 3
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed NCT03690765 - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting NCT05153512 - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Completed NCT04565470 - Strategies of Self-management of Endometriosis Symptoms
Completed NCT03613298 - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement. N/A
Withdrawn NCT05568940 - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting NCT03464799 - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting NCT03002870 - Characteristics of Patient Population With Endometriosis N/A
Withdrawn NCT03272360 - Endometriosis Biomarker Discovery Study N/A
Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4