Infertility, Female Clinical Trial
— CANOfficial title:
A Study of Cooperative Network of Diagnosis and Treatment of Uterine Adenomyosis.
NCT number | NCT03230994 |
Other study ID # | CAN201706 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 30, 2017 |
Est. completion date | December 30, 2020 |
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Women diagnosed of adenomyosis by pathology, transvaginal ultrasound or MRI. Exclusion Criteria: - Refusal to join the study |
Country | Name | City | State |
---|---|---|---|
China | Lei Li | Beijing | China/Beiing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
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, Viganò 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. Review. — View Citation
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. Review. — View Citation
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 — View Citation
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. Epub 2016 Jul 5. Review. — View Citation
Sakhel K, Abuhamad A. Sonography of adenomyosis. J Ultrasound Med. 2012 May;31(5):805-8. Review. — View Citation
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. Review. — View Citation
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): — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Therapeutic effect and Diagnostics | Symptom Assessment | 2day | |
Secondary | Pathology | Diagnostic assessment | 1day | |
Secondary | selection of therapeutic scheme | pharmacotherapy or surgery | 1day | |
Secondary | vision algetic standard(VAS) | Semeiology and evaluative criteria | 2day | |
Secondary | B type ultrasound | Diagnostic assessment | 1day | |
Secondary | Magnetic Resonance Imaging | Diagnostic assessment | 1day | |
Secondary | pictorial blood loss assessment chart(PBAC) | Semeiology and evaluative criteria | 2day |
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