Guangdong Provincial Endometriosis Clinical Research Cohort
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Li Li, MD
- 電話番号:+85213631446859
- メール:lili-1406@163.com
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、511442
- 募集
- Guangdong Women and Children Hospital
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コンタクト:
- Li Li, MD
- 電話番号:+85213631446859
- メール:lili-1406@163.com
-
コンタクト:
- Li Li, MD
- メール:lili-1406@163.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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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研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Endometriosis-Related Pain Recurrence
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Endometriosis-Related Cyst Recurrence
時間枠: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
時間枠: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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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GDWCH-ENDO-PROS-01
- 20250070 (その他の識別子:Guangdong Women and Children Hospital Ethics Committee)
- 20250134 (その他の識別子:Guangdong Women and Children Hospital Clinical Research Management Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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