Omics Sequencing of Specimen Derived From Patients With Endometriosis

Endometriosis Clinical Trial

Official title:

Omics Sequencing of Specimen Derived From Patients With Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05086484
• Other study ID #: ZhujiangHfck
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2021
• Source: Zhujiang Hospital
• Contact: Ying Ma, PhD
• Phone: 13113361169
• Email: mayingwuzhuoyi[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Endometriosis is a type of chronic inflammatory gynecological disease, mainly took place in peritoneal cavity. In order to investigate the possible correlation between microbes and endometriosis, the investigators planed to perform 16S rDNA amplicon sequencing, metagenomic sequencing and metabolomic sequencing of paired samples derived from feces, cervical mucus, blood and peritoneal fluid.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

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	16s amplicon sequencing	Compare the microbiota composition differences of specimens derived from control group and Endometriosis group.	2019/01/01-2023/12/31
Primary	metatranscriptomic sequencing	Compare the RNA concentration differences of specimens derived from control group and Endometriosis group.	2019/01/01-2023/12/31
Primary	metabolomic sequencing	Compare the metabolites concentration differences of specimens derived from control group and Endometriosis group.	2019/01/01-2023/12/31