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Clinical Trials/NCT05086484
NCT05086484
Recruiting
Not Applicable

Omics Sequencing of Specimen Derived From Patients With Endometriosis

Zhujiang Hospital1 site in 1 country1,000 target enrollmentJanuary 1, 2019
ConditionsEndometriosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Zhujiang Hospital
Enrollment
1000
Locations
1
Primary Endpoint
metabolomic sequencing
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 31, 2025
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Zhujiang Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

metabolomic sequencing

Time Frame: 2019/01/01-2023/12/31

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

16s amplicon sequencing

Time Frame: 2019/01/01-2023/12/31

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

metatranscriptomic sequencing

Time Frame: 2019/01/01-2023/12/31

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

Study Sites (1)

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