Omics Sequencing of Specimen Derived From Patients With Endometriosis

NCT ID: NCT05086484

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endometriosis group

Women diagnosed with endometriosis.

No interventions assigned to this group

Control group

Women diagnosed without endometriosis.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhujiang Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ying Ma, PhD

Role: CONTACT

13113361169

Liujing Huang, Bachelor

Role: CONTACT

15916388839

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ying Ma, PhD

Role: primary

13113361169

Liujing Huang, Bachelor

Role: backup

15916388839

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZhujiangHfck

Identifier Type: -

Identifier Source: org_study_id