Cooperative Adenomyosis Network

NCT03230994 | Unknown DMC

• 1 other identifier: CAN201706
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysmenorrhea; Metrorrhagia; Infertility, Female; Pathology; Ultrasonography; Radiography

Keywords

adenomyosis; diagnosis; treatment; epidemiology; Complications

Outcome Measures

Primary Outcomes (1)

• Therapeutic effect and Diagnostics

  Symptom Assessment

  2day

Secondary Outcomes (6)

• Pathology

  1day

• selection of therapeutic scheme

  1day

• vision algetic standard（VAS）

  2day

• B type ultrasound

  1day

• Magnetic Resonance Imaging

  1day

Study Arms (1)

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.

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

5000 women diagnosed of adenomyosis by pathology or magnetic resonance image（MRI）by experienced specialist physicians will be enrolled from nationwide multicenter.

You may qualify if:

• Women diagnosed of adenomyosis by pathology, transvaginal ultrasound or MRI.

You may not qualify if:

• Refusal to join the study

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Lei Li

Beijing, China/Beiing, 100000, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 26427702 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.

  PMID: 26772777 BACKGROUND

• 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.

  PMID: 24745831 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.

  PMID: 27379972 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.

  PMID: 27356477 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.

  PMID: 22535729 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.

  PMID: 23246186 RESULT

• 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.

  PMID: 39805535 DERIVED

Related Links

• Clinical Challenge
• Treatment Choices
• Fertility Outcome
• Medical Treatment
• ING-IUS
• Transvaginal Sonography
• MRI

MeSH Terms

Conditions

Dysmenorrhea; Metrorrhagia; Infertility, Female; Adenomyosis; Disease

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Infertility

Study Officials

• Aijun AJ SUN, MD

  Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei L Li, MD

CONTACT

139-1198-8831; lileigh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 27, 2017
• Study Start: June 30, 2017
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Within twelve months after the trial complete
• Access Criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)