EndometriosisNCT04862000
Observational Study of Patients Suffering From Endometriosis and Adenomyosis
An observational study of Endometriosis and Adenomyosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Adenomyosis
- How many people
- 880 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Apr 2021to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Patients with endometriosis or adenomyosis treated in the Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Shatin, Hong Kong
Who may be able to join
- with endometriosis or adenomyosis confirmed by ultrasound or MRI
Who cannot join
- refuse to participate in the study, less than 18 years old, menopausal, illiterate or mentally incapable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Wen Ying Fung, 852-35052748, lindafung@cuhk.edu.hk
About this study
Official title: Prospective Long Term Observational Study of Health Profile, Clinical Characteristics and Outcome of Patients Suffering From Endometriosis and Adenomyosis
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.
Read the 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
- Keywords
- Endometriosis, Adenomyosis
- Medical subject headings
- Endometriosis, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis or adenomyosis | participants suffering pelvic endometriosis, endometrioma, deep infiltrating endometriosis or adenomyosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from enrollment to end of treatment at five years.
Secondary outcomes (4)
side effects profile of medical treatment
side effects profile of medical treatment for endometriosis and adenomyosis. The bone mineral density measurement (DEXA) will be arranged if participants has prolonged usage of progestogens over 2 years. Menstrual pattern will be recorded using menstrual calendar.
Measured: from the first follow up at six months to end of treatment at five years.
ultrasound findings correlation with surgical findings
ultrasound findings correlation with surgical findings using AFS scores and Endometriosis fertility index EFI scores
Measured: from enrollment to three months post-surgery
symptoms recurrence
symptoms recurrence including pelvic pain, menstrual problems and endometrioma recurrence after medical or surgical treatments
Measured: from enrollment to end of treatment at five years.
reproductive outcome
evaluate the reproductive outcome in those participants with fertility wish. Spontaneous pregnancy rates and requirement for assisted reproductive technology after surgery will be studied, with reference to the intraoperative AFS scores.
Measured: from enrollment to end of treatment at five years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start30 Apr 2021
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fung Wen Ying Linda, Chinese University of Hong Kong
- Investigators
- Wen Ying Linda FUNG, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862000
- Sponsor's protocol ID
- CRE 2020.688
- Status last verified
- Jun 2025
- First submitted
- 27 Mar 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Long Term Observational Study of Health Profile, Clinical Characteristics and Outcome of Patients Suffering From Endometriosis and Adenomyosis
- ClinicalTrials.gov ID
- NCT04862000
- Acronym / sponsor ID
- CRE 2020.688
- Conditions
- Endometriosis, Adenomyosis
- Keywords
- Endometriosis, Adenomyosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometriosis or adenomyosis | – | –participants suffering pelvic endometriosis, endometrioma, deep infiltrating endometriosis or adenomyosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with endometriosis or adenomyosis treated in the Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Shatin, Hong Kong
Key inclusion criteria (1 listed)
- with endometriosis or adenomyosis confirmed by ultrasound or MRI
Key exclusion criteria (1 listed)
- refuse to participate in the study, less than 18 years old, menopausal, illiterate or mentally incapable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endometriosis Health Profile (EHP-30) questionnaire score
Time frame: from enrollment to end of treatment at five years.
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.
Visual Analog Scale (VAS) pain score
Time frame: from enrollment to end of treatment at five years.
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.
4 secondary outcomes
side effects profile of medical treatment
Time frame: from the first follow up at six months to end of treatment at five years.
ultrasound findings correlation with surgical findings
Time frame: from enrollment to three months post-surgery
symptoms recurrence
Time frame: from enrollment to end of treatment at five years.
reproductive outcome
Time frame: from enrollment to end of treatment at five years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wen Ying Linda FUNG principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Adenomyosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Ying Linda FUNG ((852) 55699192, lindafung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis Health Profile (EHP-30) questionnaire score (time frame: from enrollment to end of treatment at five years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.