Omics Sequencing of Specimen Derived From Patients With Endometriosis

NCT05086484 | Unknown

• 1 other identifier: ZhujiangHfck
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Keywords

Endometriosis; microbiota; metabolomic

Outcome Measures

Primary Outcomes (3)

• 16s amplicon sequencing

  Compare the microbiota composition differences of specimens derived from control group and Endometriosis group.

  2019/01/01-2023/12/31

• metatranscriptomic sequencing

  Compare the RNA concentration differences of specimens derived from control group and Endometriosis group.

  2019/01/01-2023/12/31

• metabolomic sequencing

  Compare the metabolites concentration differences of specimens derived from control group and Endometriosis group.

  2019/01/01-2023/12/31

Study Arms (2)

Endometriosis group

Women diagnosed with endometriosis.

Control group

Women diagnosed without endometriosis.

Eligibility Criteria

• Age: 18 Years - 52 Years
• Gender Eligibility Details: Women at reproductive age.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Study population are those who are admitted to Zhujiang Hospital of Southern Medical University in Guangzhou, China, due to gynecological diseases. At least two gynecologists independently screened and assessed the condition of the participants strictly according to the inclusion and exclusion criteria

You may qualify if:

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

You may not qualify if:

• The subject who has hernia.
• The subject who is pregnant.
• The subject who has malignant tumor.
• The subject who has Gene Therapy history.
• The subject who has abdominal or pelvic surgery history.
• The subject who has peritonitis.
• The subject who is below 18 years old or over 52 years old.
• The subject who can not endure laparoscopy.
• The subject who has cardiovascular disease.
• The subject who has systemic or regional acute inflammation.
• The subject who has chronic liver or kidney disease.
• The subject whoes body mass index ≤ 18.5 or ≥ 28 (kg m-2).
• The subject who has coagulation defects or hematologic diseases.
• The subject who has tuberculosis or chronic obstructive pulmonary disease.
• The subject whoes alcohol consumption ≥ 60 g d-1, or smokers (≥20 cigarettes d-1).

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ying Ma, PhD

CONTACT

13113361169; mayingwuzhuoyi@126.com

Liujing Huang, Bachelor

CONTACT

15916388839; 15916388839@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 21, 2021
• Study Start: January 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

CN (1)