Investigating the link between microbes and endometriosis

Omics Sequencing of Specimen Derived From Patients With Endometriosis

This study is trying to see if the bacteria in the body are connected to endometriosis in women who have trouble getting pregnant.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 52 Years
• Sex: Female
• Sponsor: Zhujiang Hospital (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05086484 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between microbial communities and endometriosis by conducting various sequencing techniques. Researchers will analyze paired samples from feces, cervical mucus, blood, and peritoneal fluid to identify potential correlations. The study focuses on women who are suspected to have endometriosis and are experiencing infertility or sub-fertility. By utilizing advanced sequencing methods, the study seeks to uncover insights into the microbiota and metabolomic profiles associated with this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 18-52 who are suspected to have endometriosis and are experiencing infertility or chronic pelvic pain.

Not a fit: Patients who do not have confirmed endometriosis or have undergone recent hormonal therapy or antibiotic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of endometriosis and potentially inform new treatment strategies.

How similar studies have performed: While the approach of using omics sequencing in endometriosis research is relatively novel, similar studies in other conditions have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. The subject who is female.
2. The subject who is infertility or sub-fertile.
3. The subject whose age was between 18-52 years old.
4. The subject who is suspected to have endometrioma.
5. The subject whose menstrual cycle length is between 28-35 days.
6. The subject without the history of abdominal or pelvic surgery.
7. The subject who has dysmenorrhea.
8. The subject who has dispareunia.
9. The subject who was informed the risks and benefits of the experiment and provided written informed consent, and gave their approval.
10. The subject who has chronic pelvic pain and the pain get worse during periods.
11. The subject who has no sexual activity within a week.
12. The subject who has no history of acute or chronic pelvic inflammatory disease.
13. The subject who has confirmed EM with biopsy.
14. The subject without hormonotherapy within 6 months.
15. The subject without medical history of antibiotics within 6 months.

Exclusion Criteria:

1. The subject who has hernia.
2. The subject who is pregnant.
3. The subject who has malignant tumor.
4. The subject who has Gene Therapy history.
5. The subject who has abdominal or pelvic surgery history.
6. The subject who has peritonitis.
7. The subject who is below 18 years old or over 52 years old.
8. The subject who can not endure laparoscopy.
9. The subject who has cardiovascular disease.
10. The subject who has systemic or regional acute inflammation.
11. The subject who has chronic liver or kidney disease.
12. The subject whoes body mass index ≤ 18.5 or ≥ 28 (kg m-2).
13. The subject who has coagulation defects or hematologic diseases.
14. The subject who has tuberculosis or chronic obstructive pulmonary disease.
15. The subject whoes alcohol consumption ≥ 60 g d-1, or smokers (≥20 cigarettes d-1).
16. The subject who has hypertension, diabetes, hyperthyroidism and ect.
17. The subject whoes medical history of transfusion, stem cell or bone marrow transplantation.
18. The subject who has contraindication of tracheal intubation anesthesia.
19. The subject who received hormonotherapy within 6 months.
20. The subject who has immunodeficient, allergic or autoimmune diseases.
21. The subject who used antibiotics within 6 months.
22. The subject who is drug abuse.

Where this trial is running

Guangzhou, Guangdong

• Zhujiang Hospital — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Ying Ma, PhD

Conditions: Endometriosis, microbiota, metabolomic