Postoperative Cyclic Oral Contraceptive Use for the Prevention of Endometrioma Recurrence

NCT ID: NCT01092494

Last Updated: 2010-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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OC use

OC use after postoperative gonadotropin-releasing hormone agonist treatment

No interventions assigned to this group

OC non-use

Only postoperative gonadotropin-releasing hormone agonist treatment

No interventions assigned to this group

Eligibility Criteria

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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

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Principal Investigators

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DooSeok Choi

Role: STUDY_DIRECTOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Central Contacts

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DooSeok Choi, MD, PhD

Role: CONTACT

82-2-3410-3514

Facility Contacts

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DooSeok Choi

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 18976968 (View on PubMed)

Other Identifiers

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2010-02-020

Identifier Type: -

Identifier Source: org_study_id

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