Cooperative Adenomyosis Network

• Conditions: Infertility, Female; Ultrasonography; Dysmenorrhea; Metrorrhagia; Pathology; Radiography

• Registration Number: NCT03230994
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-06-30
• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-27
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-09
• Last Update Posted: 2018-11-13
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 5000

Inclusion Criteria

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

Exclusion Criteria

• Refusal to join the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapeutic effect and Diagnostics	2day	Symptom Assessment

Secondary Outcome Measures

Name	Time	Method
Pathology	1day	Diagnostic assessment
selection of therapeutic scheme	1day	pharmacotherapy or surgery
vision algetic standard（VAS）	2day	Semeiology and evaluative criteria
B type ultrasound	1day	Diagnostic assessment
Magnetic Resonance Imaging	1day	Diagnostic assessment
pictorial blood loss assessment chart（PBAC）	2day	Semeiology and evaluative criteria

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, China/Beiing, China