Ovarian EndometriomaNCT07519213
Guangdong Endometriosis Retrospective Clinical Cohort
An observational study of Ovarian Endometrioma and Endometriosis, run by Guangdong Women and Children Hospital at 1 site in China.
Trial summary
This retrospective cohort study evaluates the association between postoperative hormonal treatment and recurrence of ovarian endometriosis in women undergoing surgery for ovarian endometrioma. The study includes patients treated at a single center who initiated one postoperative hormonal regimen after surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovarian Endometrioma, Endometriosis
- Type of treatment
- Pill or oral medicine
- How many people
- 1,121 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with ovarian endometrioma who underwent conservative surgery at a single study center and subsequently received postoperative hormonal therapy in routine clinical practice.
Who may be able to join
- Female patients who underwent conservative surgery for ovarian endometrioma at the study center.
- Initiation of one postoperative hormonal regimen within 1 month after surgery.
- Continuous use of the same single hormonal regimen for at least 6 months after surgery.
- Availability of clinical records and postoperative follow-up data for assessment of study outcomes.
Who cannot join
- Failure to initiate postoperative hormonal therapy within 1 month after surgery.
- Discontinuation of the postoperative hormonal regimen before 6 months.
- Use of sequential or multiple postoperative hormonal therapies during the initial treatment period.
- Incomplete clinical records or insufficient follow-up data for evaluation of recurrence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guangdong Retrospective Clinical Cohort Study of Endometriosis
This retrospective cohort study evaluates the association between postoperative hormonal treatment and recurrence of ovarian endometriosis in women undergoing surgery for ovarian endometrioma. The study includes patients treated at a single center who initiated one postoperative hormonal regimen after surgery. The main objective is to compare the risk of recurrence among women receiving combined oral contraceptives, gonadotropin-releasing hormone agonists, dienogest, or dydrogesterone. Recurrence is assessed during follow-up based on postoperative clinical and ultrasound findings. The results may help clarify the comparative effectiveness of commonly used postoperative hormonal strategies for reducing recurrence after surgery for ovarian endometrioma.
Read the detailed description
This is a single-center retrospective cohort study designed to evaluate the association between postoperative hormonal therapy and recurrence of ovarian endometrioma after conservative surgery.
Women who underwent surgery for ovarian endometrioma at the study center were screened for eligibility. Patients were included if they initiated one postoperative hormonal regimen within 1 month after surgery and continued the same single-agent treatment for at least 6 months. Patients who did not meet the continuous treatment requirement, received sequential hormonal therapy, or otherwise failed to meet the eligibility criteria were excluded.
Eligible participants were classified into 4 cohorts according to the postoperative hormonal regimen received: combined oral contraceptives (COC), gonadotropin-releasing hormone agonists (GnRH-a), dienogest (DNG), and dydrogesterone. The study was observational in nature, and treatment allocation was based on routine clinical practice rather than assignment by investigators.
The primary objective is to compare recurrence risk among the 4 postoperative hormonal treatment groups. Recurrence is defined as a newly detected ovarian cyst measuring at least 2 cm on ultrasound and documented on at least 2 examinations during follow-up. Follow-up focuses on recurrence within 2 years after surgery.
Clinical, demographic, and disease-related characteristics are collected from medical records and follow-up data. These variables include baseline patient characteristics, reproductive history, disease severity, and relevant surgical findings. The study aims to assess the comparative effectiveness of commonly used postoperative hormonal strategies for long-term management after conservative surgery for ovarian endometrioma.
Because this is a retrospective observational study, no study intervention is assigned as part of the protocol. The findings are expected to provide real-world evidence regarding postoperative medical management and recurrence prevention in women with ovarian endometrioma.
- Conditions
- Ovarian Endometrioma, Endometriosis
- Keywords
- postoperative hormonal therapy, recurrence, conservative surgery, combined oral contraceptives, gonadotropin-releasing hormone agonist, dienogest, dydrogesterone, retrospective cohort
- Medical subject headings
- Endometriosis, Recurrence
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 |
|---|---|---|
| COC | Participants who received combined oral contraceptives as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma. | |
| GnRH-a | Participants who received gonadotropin-releasing hormone agonists as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma. | |
| DNG | Participants who received dienogest as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma. | |
| Dydrogesterone | Participants who received dydrogesterone as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of ovarian endometrioma within 2 years after surgery
Recurrence is defined as a newly detected ovarian cyst measuring at least 2 cm on ultrasound and documented on at least 2 separate examinations during follow-up.
Measured: Within 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Sep 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian EndometriomaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519213
- Sponsor's protocol ID
- GuangdongWCH-Li Li04
- Other IDs
- Identifier: IEC [2026]160, Identifier:MR-44-26-047686
- Status last verified
- May 2026
- First submitted
- 2 Apr 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schrager S, Yogendran L, Marquez CM, Sadowski EA. Adenomyosis: Diagnosis and Management. Am Fam Physician. 2022 Jan 1;105(1):33-38.
PubMed 35029928As-Sanie S, Mackenzie SC, Morrison L, Schrepf A, Zondervan KT, Horne AW, Missmer SA. Endometriosis: A Review. JAMA. 2025 Jul 1;334(1):64-78. doi: 10.1001/jama.2025.2975.
PubMed 40323608Becker CM, Bokor A, Heikinheimo O, Horne A, Jansen F, Kiesel L, King K, Kvaskoff M, Nap A, Petersen K, Saridogan E, Tomassetti C, van Hanegem N, Vulliemoz N, Vermeulen N; ESHRE Endometriosis Guideline Group. ESHRE guideline: endometriosis. Hum Reprod Open. 2022 Feb 26;2022(2):hoac009. doi: 10.1093/hropen/hoac009. eCollection 2022.
PubMed 35350465
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guangdong Retrospective Clinical Cohort Study of Endometriosis
- ClinicalTrials.gov ID
- NCT07519213
- Acronym / sponsor ID
- GuangdongWCH-Li Li04
- Conditions
- Ovarian Endometrioma, Endometriosis
- Keywords
- postoperative hormonal therapy, recurrence, conservative surgery, combined oral contraceptives, gonadotropin-releasing hormone agonist, dienogest, dydrogesterone, retrospective cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,121 participants (actual)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 9 Apr 2026 (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.
This retrospective cohort study evaluates the association between postoperative hormonal treatment and recurrence of ovarian endometriosis in women undergoing surgery for ovarian endometrioma. The study includes patients treated at a single center who initiated one postoperative hormonal regimen after surgery. The main objective is to compare the risk of recurrence among women receiving combined oral contraceptives, gonadotropin-releasing hormone agonists, dienogest, or dydrogesterone. Recurrence is assessed during follow-up based on postoperative clinical and ultrasound findings. The results may help clarify the comparative effectiveness of commonly used postoperative hormonal strategies for reducing recurrence after surgery for ovarian endometrioma.
Detailed description
This is a single-center retrospective cohort study designed to evaluate the association between postoperative hormonal therapy and recurrence of ovarian endometrioma after conservative surgery.
Women who underwent surgery for ovarian endometrioma at the study center were screened for eligibility. Patients were included if they initiated one postoperative hormonal regimen within 1 month after surgery and continued the same single-agent treatment for at least 6 months. Patients who did not meet the continuous treatment requirement, received sequential hormonal therapy, or otherwise failed to meet the eligibility criteria were excluded.
Eligible participants were classified into 4 cohorts according to the postoperative hormonal regimen received: combined oral contraceptives (COC), gonadotropin-releasing hormone agonists (GnRH-a), dienogest (DNG), and dydrogesterone. The study was observational in nature, and treatment allocation was based on routine clinical practice rather than assignment by investigators.
The primary objective is to compare recurrence risk among the 4 postoperative hormonal treatment groups. Recurrence is defined as a newly detected ovarian cyst measuring at least 2 cm on ultrasound and documented on at least 2 examinations during follow-up. Follow-up focuses on recurrence within 2 years after surgery.
Clinical, demographic, and disease-related characteristics are collected from medical records and follow-up data. These variables include baseline patient characteristics, reproductive history, disease severity, and relevant surgical findings. The study aims to assess the comparative effectiveness of commonly used postoperative hormonal strategies for long-term management after conservative surgery for ovarian endometrioma.
Because this is a retrospective observational study, no study intervention is assigned as part of the protocol. The findings are expected to provide real-world evidence regarding postoperative medical management and recurrence prevention in women with ovarian endometrioma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COC | – | –Participants who received combined oral contraceptives as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma. |
| GnRH-a | – | –Participants who received gonadotropin-releasing hormone agonists as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma. |
| DNG | – | –Participants who received dienogest as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma. |
| Dydrogesterone | – | –Participants who received dydrogesterone as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with ovarian endometrioma who underwent conservative surgery at a single study center and subsequently received postoperative hormonal therapy in routine clinical practice.
Key inclusion criteria (4 listed)
- Female patients who underwent conservative surgery for ovarian endometrioma at the study center.
- Initiation of one postoperative hormonal regimen within 1 month after surgery.
- Continuous use of the same single hormonal regimen for at least 6 months after surgery.
- Availability of clinical records and postoperative follow-up data for assessment of study outcomes.
Key exclusion criteria (4 listed)
- Failure to initiate postoperative hormonal therapy within 1 month after surgery.
- Discontinuation of the postoperative hormonal regimen before 6 months.
- Use of sequential or multiple postoperative hormonal therapies during the initial treatment period.
- Incomplete clinical records or insufficient follow-up data for evaluation of recurrence.
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
Recurrence of ovarian endometrioma within 2 years after surgery
Time frame: Within 2 years after surgery
Recurrence is defined as a newly detected ovarian cyst measuring at least 2 cm on ultrasound and documented on at least 2 separate examinations during follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 35029928Schrager S, Yogendran L, Marquez CM, Sadowski EA. Adenomyosis: Diagnosis and Management. Am Fam Physician. 2022 Jan 1;105(1):33-38.
- Background: PubMed 40323608As-Sanie S, Mackenzie SC, Morrison L, Schrepf A, Zondervan KT, Horne AW, Missmer SA. Endometriosis: A Review. JAMA. 2025 Jul 1;334(1):64-78. doi: 10.1001/jama.2025.2975.
- Background: PubMed 35350465Becker CM, Bokor A, Heikinheimo O, Horne A, Jansen F, Kiesel L, King K, Kvaskoff M, Nap A, Petersen K, Saridogan E, Tomassetti C, van Hanegem N, Vulliemoz N, Vermeulen N; ESHRE Endometriosis Guideline Group. ESHRE guideline: endometriosis. Hum Reprod Open. 2022 Feb 26;2022(2):hoac009. doi: 10.1093/hropen/hoac009. eCollection 2022.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Ovarian Endometrioma and Endometriosis, run by Guangdong Women and Children Hospital at 1 site in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jul 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of ovarian endometrioma within 2 years after surgery (time frame: Within 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07519213, which also lists 3 linked publications.
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 8 Jul 2026.