Guangdong Provincial Endometriosis Clinical Research Cohort
연구 개요
상태
상태
정황
정황
상세 설명
This is a prospective observational cohort study designed to characterize the clinical course and reproductive outcomes of women with endometriosis. The study will prospectively enroll women aged 18 to 45 years with a clinical, imaging, or surgical diagnosis of endometriosis. Age- and body mass index-matched healthy women with regular menstrual cycles may also be enrolled as a control cohort.
Baseline data will include demographic characteristics, reproductive history, lifestyle factors, clinical symptoms, pain scores, disease phenotype, lesion characteristics, rASRM stage, previous surgery, laboratory findings, ovarian reserve indicators, and assisted reproductive treatment information, when applicable. Treatments received as part of routine clinical care, including gonadotropin-releasing hormone agonists and progestogens, will be recorded as observational exposures. The study protocol will not assign participants to a specific medication, procedure, or assisted reproductive treatment.
Participants will be followed for 24 months. Follow-up assessments will be conducted every 3 months during the first year and every 6 months thereafter, with clinically important outcome events recorded when they occur. Outcomes of interest include cyst recurrence, pain recurrence, pregnancy outcomes, live birth, and other long-term clinical complications.
Associations between baseline clinical characteristics, disease severity, routine treatment patterns, and subsequent outcomes will be evaluated using appropriate descriptive and multivariable statistical methods. Time-to-event outcomes may be analyzed using Kaplan-Meier methods and Cox proportional hazards regression, with adjustment for potential confounding factors.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Li Li, MD
- 전화번호: +85213631446859
- 이메일: lili-1406@163.com
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국, 511442
- 모병
- Guangdong Women and Children Hospital
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연락하다:
- Li Li, MD
- 전화번호: +85213631446859
- 이메일: lili-1406@163.com
-
연락하다:
- Li Li, MD
- 이메일: lili-1406@163.com
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Inclusion Criteria:
Female participants aged 18 to 45 years. Able and willing to provide written informed consent. For the endometriosis cohort: diagnosis of endometriosis based on clinical findings, imaging, and/or laparoscopy.
For the endometriosis cohort: availability of complete baseline clinical data, including revised American Society for Reproductive Medicine stage and lesion type.
For the healthy control cohort: healthy women matched by age and body mass index to participants in the endometriosis cohort.
For the healthy control cohort: regular menstrual cycles of 28 to 30 days.
Exclusion Criteria:
For the endometriosis cohort: concurrent malignant tumor or severe cardiac, hepatic, or renal disease.
For the endometriosis cohort: previous hysterectomy. For the endometriosis cohort: a mental disorder that prevents adherence to study follow-up.
Exclusion Criteria:
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
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Endometriosis Cohort
Women aged 18 to 45 years with endometriosis diagnosed based on clinical findings, imaging, and/or laparoscopy will be prospectively enrolled and followed for 24 months.
Baseline disease characteristics, routine clinical treatments, pain outcomes, cyst recurrence, and reproductive outcomes will be recorded.
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Healthy Control Cohort
Age- and body mass index-matched healthy women aged 18 to 45 years with regular menstrual cycles of 28 to 30 days will be prospectively enrolled as a comparison cohort.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Endometriosis-Related Pain Recurrence
기간: From enrollment through 24 months
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The number and percentage of participants in the endometriosis cohort who experience recurrence of endometriosis-related pain during follow-up.
Pain severity will be assessed using a visual analogue scale and clinical symptom records
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From enrollment through 24 months
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Endometriosis-Related Cyst Recurrence
기간: From enrollment through 24 months
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The number and percentage of participants in the endometriosis cohort with a recurrent endometriosis-related cyst documented during follow-up.
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From enrollment through 24 months
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Live Birth During Follow-Up
기간: From enrollment through 24 months
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The number and percentage of participants in the endometriosis cohort with a live birth during follow-up.
Live birth is defined as delivery of a live infant at 28 gestational weeks or later.
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From enrollment through 24 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Sharma S, Bathwal S, Agarwal N, Chattopadhyay R, Saha I, Chakravarty B. Does presence of adenomyosis affect reproductive outcome in IVF cycles? A retrospective analysis of 973 patients. Reprod Biomed Online. 2019 Jan;38(1):13-21. doi: 10.1016/j.rbmo.2018.09.014. Epub 2018 Oct 26.
- Marcellin L, Leconte M, Gaujoux S, Santulli P, Borghese B, Chapron C, Dousset B. Associated ileocaecal location is a marker for greater severity of low rectal endometriosis. BJOG. 2019 Dec;126(13):1600-1608. doi: 10.1111/1471-0528.15901. Epub 2019 Sep 4.
- Rowlands IJ, Abbott JA, Montgomery GW, Hockey R, Rogers P, Mishra GD. Prevalence and incidence of endometriosis in Australian women: a data linkage cohort study. BJOG. 2021 Mar;128(4):657-665. doi: 10.1111/1471-0528.16447. Epub 2020 Sep 1.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- GDWCH-ENDO-PROS-01
- 20250070 (기타 식별자: Guangdong Women and Children Hospital Ethics Committee)
- 20250134 (기타 식별자: Guangdong Women and Children Hospital Clinical Research Management Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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