Postoperative Cyclic Oral Contraceptive Use for the Prevention of Endometrioma Recurrence

NCT01092494 | Unknown

• 1 other identifier: 2010-02-020
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis

Keywords

Endometrioma recurrence; oral contraceptives; gonadotropin-releasing hormone agonist

Outcome Measures

Primary Outcomes (1)

• recurrence rate of endometrioma

  60 months

Study Arms (2)

OC use

OC use after postoperative gonadotropin-releasing hormone agonist treatment

OC non-use

Only postoperative gonadotropin-releasing hormone agonist treatment

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

Location

Related Publications (1)

• Park HJ, Koo YA, Yoon BK, Choi D. Postoperative long-term maintenance therapy with oral contraceptives after gonadotropin-releasing hormone analog treatment in women with ovarian endometrioma. J Minim Invasive Gynecol. 2009 Jan-Feb;16(1):34-9. doi: 10.1016/j.jmig.2008.09.582. Epub 2008 Oct 30.

  PMID: 18976968 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• DooSeok Choi

  Samsung Medical Center

  STUDY DIRECTOR

Central Study Contacts

DooSeok Choi, MD, PhD

CONTACT

82-2-3410-3514; dooseok.choi@samsung.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 25, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 25, 2010

Record last verified: 2010-03

Locations

KR (1)