Postoperative Hormonal Therapy and Recurrence After Surgery for Ovarian Endometrioma

May 28, 2026 updated by: Li Li, Guangdong Women and Children Hospital

Comparative Effectiveness of Postoperative Hormonal Regimens After Ovarian Endometrioma Cystectomy: A Weighted Retrospective Cohort Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 511400
        • Guangdong Women and Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within 2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Women and Children Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GuangdongWCH-Li Li04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings