Postoperative Cyclic Oral Contraceptive Use for the Prevention of Endometrioma Recurrence

March 24, 2010 updated by: Samsung Medical Center

Efficacy of Postoperative Cyclic Oral Contraceptive Use After Gonadotropin-releasing Hormone Agonist for the Prevention of Endometrioma Recurrence

Ovarian endometriotic cyst (endometrioma) is one of the most common endometriotic lesions, and conservative laparoscopic surgery is the treatment of choice. However, the recurrence after surgery is common.

As repetitive surgery leads to morbidities and ovarian function decrease, recurrence after surgery frustrates both patients and clinicians. In this aspect, medical treatments have been offered after surgery to prevent or delay the recurrence. Gonadotropin-releasing hormone agonist (GnRHa) is frequently used in women with advanced endometriosis, but the efficacy is rather controversial. On the other hand, it has been demonstrated that oral contraceptives (OCs) could reduce or delay endometrioma recurrence, but data are still limited. Consequently, no one type of postoperative medical therapy has been shown to be superior in reducing the recurrence of endometrioma.

The rationale of postoperative medical therapy is that it could eradicate microscopic lesions which were not found and not treated sufficiently during surgery. Therefore, the maintenance of strongly suppressed condition induced by postoperative GnRHa treatment by addition of OCs could be a promising treatment to prevent the recurrence, but it has not been widely investigated.

We performed this retrospective cohort study to evaluate the efficacy of cyclic monophasic low-dose OCs as a maintenance therapy after GnRHa treatment for the suppression of endometrioma recurrence.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

232

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

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

15 years to 49 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Reproductive aged women who underwent conservative laparoscopic surgery for ovarian endometrioma and followed up at Samsung Medical Center between January 2000 and December 2007.

Description

Inclusion Criteria:

  1. reproductive aged women who underwent conservative laparoscopic ovarian surgery for endometrioma (ASRM stage III/IV) which was confirmed by pathologic inspection
  2. women who were given postoperative GnRHa injections every 28 days for 3 or 6 months
  3. women with no residual lesion confirmed by ultrasonography after surgery
  4. women who were followed up for over 12 months after surgery.

Exclusion Criteria:if they had

  1. undergone hysterectomy during an operation
  2. been given GnRHa injections more than 6 times
  3. been given other types of postoperative treatment (progestin or intrauterine device)
  4. a history of previous pelvic surgery for endometriosis
  5. a history of hormonal treatment before surgery
  6. been diagnosed as menopause after surgery
  7. contraindications to OCs
  8. been identified ovarian endometriomas within 6 months of postoperative evaluation

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
OC use
OC use after postoperative gonadotropin-releasing hormone agonist treatment
OC non-use
Only postoperative gonadotropin-releasing hormone agonist treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
recurrence rate of endometrioma
Time Frame: 60 months
60 months

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Study Director: DooSeok Choi, Samsung Medical Center

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

March 1, 2010

Primary Completion (ANTICIPATED)

March 1, 2010

Study Completion (ANTICIPATED)

March 1, 2010

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (ESTIMATE)

March 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2010

Last Update Submitted That Met QC Criteria

March 24, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-02-020

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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