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To set up a Cooperative Network by enrolling 5000 patients with Adenomyosis(AM) from multiple centers.Based on the Network platform and Database,the investigators try to explore the diagnostic strategies for AM and carry out epidemiological survey on the semeiology of AM.In addiction，the investigators expect to conduct research on the effect and the follow-up fertility outcomes of different medical or surgical treatment, the etiology of AM and endometriosis,the perspective investigation of the malignant transformation of AM ;the high-risk factors of AM,and finally propel the formation of Expert Consensus and Clinical Guidelines about AM which suitable to chinese conditions.
5000 women diagnosed of Adenomyosis(AM) with pathology, transvaginal ultrasonography or magnetic resonance image（MRI）will be enrolled from nationwide multicenters. The investigators would build up Network platform, and database with the registered data within 6 months. 30-month follow-up with an interval of at least once every 6 months will be done for every patient ，and update the database timely.
Based on the Network platform and Database,we try to explore the diagnostic strategies for AM and carry out epidemiological survey on the semeiology of AM.In addiction，the investigators expect to conduct research on the effect and the follow-up fertility outcomes of different medical or surgical treatment,the etiology of AM and endometriosis,the perspective investigation of the malignant transformation of AM ;the high-risk factors of AM,and finally propel the formation of Expert Consensus and Clinical Guidelines about AM which suitable to chinese conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Different Treatment Groups | Women would receive different pharmacotherapy from the standard approach，such as levonorgestrel-releasing intrauterine system(LNG-IUS)，Gonadotrophin releasing hormone agonist(GnRH-a),surgery,etc. |
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| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic effect and Diagnostics | Symptom Assessment | 2day |
| Measure | Description | Time Frame |
|---|---|---|
| Pathology | Diagnostic assessment | 1day |
| selection of therapeutic scheme | pharmacotherapy or surgery | 1day |
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Inclusion Criteria:
Exclusion Criteria:
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5000 women diagnosed of adenomyosis by pathology or magnetic resonance image（MRI）by experienced specialist physicians will be enrolled from nationwide multicenter.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei L Li, MD | Contact | 139-1198-8831 | ＋86 | lileigh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Aijun AJ SUN, MD | Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | China/Beiing | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26427702 | Background | Struble J, Reid S, Bedaiwy MA. Adenomyosis: A Clinical Review of a Challenging Gynecologic Condition. J Minim Invasive Gynecol. 2016 Feb 1;23(2):164-85. doi: 10.1016/j.jmig.2015.09.018. Epub 2015 Sep 30. | |
| 26772777 | Background | Alabiso G, Alio L, Arena S, Barbasetti di Prun A, Bergamini V, Berlanda N, Busacca M, Candiani M, Centini G, Di Cello A, Exacoustos C, Fedele L, Fuggetta E, Gabbi L, Geraci E, Imperiale L, Lavarini E, Incandela D, Lazzeri L, Luisi S, Maiorana A, Maneschi F, Mannini L, Mattei A, Muzii L, Pagliardini L, Perandini A, Perelli F, Pinzauti S, Porpora MG, Remorgida V, Leone Roberti Maggiore U, Seracchioli R, Solima E, Somigliana E, Tosti C, Venturella R, Vercellini P, Vigano P, Vignali M, Zannoni L, Zullo F, Zupi E; Endometriosis Treatment Italian Club. Adenomyosis: What the Patient Needs. J Minim Invasive Gynecol. 2016 May-Jun;23(4):476-88. doi: 10.1016/j.jmig.2015.12.017. Epub 2016 Jan 6. |
| Label | URL |
|---|---|
| Clinical Challenge | View source |
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Network platform, and the website will be attached later.
Within twelve months after the trial complete
Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2017 | Jul 3, 2017 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2017 | Jul 3, 2017 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D008796 | Metrorrhagia |
| D007247 | Infertility, Female |
| D062788 | Adenomyosis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| vision algetic standard（VAS） | Semeiology and evaluative criteria | 2day |
| B type ultrasound | Diagnostic assessment | 1day |
| Magnetic Resonance Imaging | Diagnostic assessment | 1day |
| pictorial blood loss assessment chart（PBAC） | Semeiology and evaluative criteria | 2day |
| 24745831 | Result | Vercellini P, Consonni D, Barbara G, Buggio L, Frattaruolo MP, Somigliana E. Adenomyosis and reproductive performance after surgery for rectovaginal and colorectal endometriosis: a systematic review and meta-analysis. Reprod Biomed Online. 2014 Jun;28(6):704-13. doi: 10.1016/j.rbmo.2014.02.006. Epub 2014 Mar 4. |
| 27379972 | Result | Pontis A, D'Alterio MN, Pirarba S, de Angelis C, Tinelli R, Angioni S. Adenomyosis: a systematic review of medical treatment. Gynecol Endocrinol. 2016 Sep;32(9):696-700. doi: 10.1080/09513590.2016.1197200. Epub 2016 Jul 5. |
| 27356477 | Result | Li L, Leng JH, Shi JH, Zhang JJ, Jia SZ, Li XY, Dai Y, Zhang JR, Li T, Xu XX, Liu ZZ, You SS, Chang XY, Lang JH. [A prospective study on the effects of levonorgestrel-releasing intrauterine system for adenomyosis with menorrhagia]. Zhonghua Fu Chan Ke Za Zhi. 2016 Jun 25;51(6):424-30. doi: 10.3760/cma.j.issn.0529-567X.2016.06.005. Chinese. |
| 22535729 | Result | Sakhel K, Abuhamad A. Sonography of adenomyosis. J Ultrasound Med. 2012 May;31(5):805-8. doi: 10.7863/jum.2012.31.5.805. No abstract available. |
| 23246186 | Result | Levy G, Dehaene A, Laurent N, Lernout M, Collinet P, Lucot JP, Lions C, Poncelet E. An update on adenomyosis. Diagn Interv Imaging. 2013 Jan;94(1):3-25. doi: 10.1016/j.diii.2012.10.012. Epub 2012 Dec 12. |
| 39805535 | Derived | Chen X, Lang J, Li L. Adenomyosis Patterns on Transvaginal Sonography Could Predict the Obstetrical Outcomes of Fertility-Sparing Surgeries: A Retrospective Cohort Study. J Minim Invasive Gynecol. 2025 Jun;32(6):540-549. doi: 10.1016/j.jmig.2025.01.003. Epub 2025 Jan 11. |
| Treatment Choices | View source |
| Fertility Outcome | View source |
| Medical Treatment | View source |
| ING-IUS | View source |
| Transvaginal Sonography | View source |
| MRI | View source |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D007246 | Infertility |