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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

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
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

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

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)

September 1, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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