Observational Study of Patients Suffering From Endometriosis and Adenomyosis

NCT04862000 | Recruiting

• 1 other identifier: CRE 2020.688
• Study Type: observational
• Target: 880
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis and adenomyosis are chronic difficult diseases affecting a significant proportion of reproductive age women. it is hoped that the investigators can collect the health profile of these participants using structured questionnaires on their quality of life, reproductive health, collect the sonographic characteristics, identify the risks factors of participants suffering from severe disease, and to propose the best treatment modality for different patient groups, both with and without fertility wish.

Conditions

Endometriosis; Adenomyosis

Keywords

Endometriosis; Adenomyosis

Outcome Measures

Primary Outcomes (2)

• Endometriosis Health Profile (EHP-30) questionnaire score

  The Endometriosis Health Profile-30 (EHP-30) is a disease-specific questionnaire to measure the health-related quality of life in patients with endometriosis. EHP-30 score is ranging from 0 (best health status) to 100 (worst health status). EHP-30 questionnaire score before and after medical and surgical treatment will be evaluated.

  from enrollment to end of treatment at five years.

• Visual Analog Scale (VAS) pain score

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by participant making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Mean change in pain score on VAS before and after medical and surgical treatment will be evaluated.

  from enrollment to end of treatment at five years.

Secondary Outcomes (4)

• side effects profile of medical treatment

  from the first follow up at six months to end of treatment at five years.

• ultrasound findings correlation with surgical findings

  from enrollment to three months post-surgery

• symptoms recurrence

  from enrollment to end of treatment at five years.

• reproductive outcome

  from enrollment to end of treatment at five years.

Study Arms (1)

Endometriosis or adenomyosis

participants suffering pelvic endometriosis, endometrioma, deep infiltrating endometriosis or adenomyosis

Eligibility Criteria

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

Study Population

Patients with endometriosis or adenomyosis treated in the Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Shatin, Hong Kong

You may qualify if:

• with endometriosis or adenomyosis confirmed by ultrasound or MRI

You may not qualify if:

• refuse to participate in the study, less than 18 years old, menopausal, illiterate or mentally incapable

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Endometriosis; Adenomyosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Diseases

Study Officials

• Wen Ying Linda FUNG

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Ying Linda FUNG

CONTACT

(852) 55699192; lindafung@cuhk.edu.hk

Sau Fung Jennifer TSANG

CONTACT

(852) 24668092; jennifert@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 27, 2021
• Study Start: April 30, 2021
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)