Postoperative Cyclic Oral Contraceptive Use for the Prevention of Endometrioma Recurrence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Samsung Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01092494
First received: March 23, 2010
Last updated: March 24, 2010
Last verified: March 2010
  Purpose

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.


Condition
Endometriosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficacy of Postoperative Cyclic Oral Contraceptive Use After Gonadotropin-releasing Hormone Agonist for the Prevention of Endometrioma Recurrence

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • recurrence rate of endometrioma [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 232
Study Start Date: March 2010
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
OC use
OC use after postoperative gonadotropin-releasing hormone agonist treatment
OC non-use
Only postoperative gonadotropin-releasing hormone agonist treatment

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092494

Contacts
Contact: DooSeok Choi, MD, PhD 82-2-3410-3514 dooseok.choi@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: DooSeok Choi       dooseok.choi@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Director: DooSeok Choi Samsung Medical Center
  More Information

Publications:
Responsible Party: DooSeok Choi, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01092494     History of Changes
Other Study ID Numbers: 2010-02-020
Study First Received: March 23, 2010
Last Updated: March 24, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Endometrioma recurrence
oral contraceptives
gonadotropin-releasing hormone agonist

Additional relevant MeSH terms:
Endometriosis
Recurrence
Genital Diseases, Female
Disease Attributes
Pathologic Processes
Hormones
Contraceptive Agents
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 16, 2014