Observational Study of Patients Suffering From Endometriosis and Adenomyosis

NCT ID: NCT04862000

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 880 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2032-12-31

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.

Detailed Description

Endometriosis and adenomyosis are chronic difficult diseases affecting a significant proportion of reproductive age women. Not only the disease can lead to chronic pelvic pain, dyspareunia and dysmenorrhea, it is also associated with impaired reproductive health, infertility and tubal-peritoneal disease. Adenomyosis can also result in anaemia due to the increased uterine volume and menstrual blood loss. Different treatment options are available for this group of participants, ranging from simple medical treatment to control symptoms, such as analgesics for pain control, transexemic acid to reduce menstrual blood loss, to hormonal treatment and the more radical surgical treatment.

As a tertiary gynaecology referral centre, the investigators encounter a large volume of patients suffering from endometriosis and adenomyosis of different disease severity. Through this prospective observational study, it is hoped that the investigators can collect the health profile of participants using structured questionnaires on their quality of life, reproductive health, collect the sonographic characteristics, identify the risks factors of patients suffering from severe disease, and to propose the best treatment modality for different participant groups, both with and without fertility wish.

Patients attending the pelvic mass clinic/ endometriosis clinic with the histologically confirmed or sonographic evidence of endometriosis/ adenomyosis will be invited to participate in the prospective study. Their demographic data will be collected. Symptomatology and health profile will be collected via questionnaires (e.g.EHP-30, SF 36, FSFI) to evaluate the physical, psychological, sexual and social aspects of patients affecting by the disease. Menstrual chart with be recorded. Physical examination including abdominal and pelvic examination will be performed. Pelvic sonography will be offered and recorded systematically. Different medical/ surgical treatments will be offered based on patient's clinical condition in an evidence-based approach and clinical guidance. Their treatment outcome will be assessed during the follow-up. Surgical findings will be recorded and disease severity graded by use of AFS scores. Pathological findings will be evaluated.

Conditions

Endometriosis; Adenomyosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endometriosis or adenomyosis

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• with endometriosis or adenomyosis confirmed by ultrasound or MRI

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Fung Wen Ying Linda

Associate Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wen Ying Linda FUNG

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Wen Ying Linda FUNG

Role: CONTACT

lindafung@cuhk.edu.hk

(852) 55699192

Sau Fung Jennifer TSANG

Role: CONTACT

jennifert@cuhk.edu.hk

(852) 24668092

Facility Contacts

Wen Ying Fung

Role: primary

lindafung@cuhk.edu.hk

852-35052748

Other Identifiers

CRE 2020.688

Identifier Type: -

Identifier Source: org_study_id