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Endometrioma Related Reduced Ovarian Reserve

NCT ID: NCT02438735

Last Updated: 2017-12-19

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

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-08-01

Brief Summary

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Prior studies have shown surgical excision of endometriomas are associated with a decline in ovarian reserve as assessed by serum anti-Mullerian Hormone (AMH) levels. However, the natural history of serum AMH levels in the presence of untreated endometriomas are unknown. Purpose of this study is to determine whether the presence of endometriomas cause a faster decline in serum AMH levels than in healthy women over a six months period.

Detailed Description

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The study is a prospective cohort study. Women diagnosed with endometriomas by transvaginal or transabdominal ultrasound or MRI will be recruited from a tertiary care endometriosis clinic. Age matched healthy controls will be recruited from the staff of the same hospital. A priorly published historical group of women who underwent endometrioma excision will be a second comparator.

Conditions

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Endometriosis

Keywords

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ovarian endometriomas AMH ovarian reserve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Endometrioma

Reproductive aged women diagnosed with endometrioma. Conservative follow up for six months.

Conservative follow up

Intervention Type OTHER

Healthy Controls

Women with regular menstrual cycles and without ovarian pathology will be recruited from physicians, nurses and other staff of the same hospital.

Controls will be matched for age with the women in the endometrioma group. They will be conservatively followed up for six months.

Conservative follow up

Intervention Type OTHER

Historical controls who underwent surgical excision

20 women who underwent surgical excision of endometrioma in the same clinic had serum AMH levels measured preoperatively and on post operative sixth month. Their values will be compared with that of endometrioma group. These data were priorly published in detail (Uncu et al. 2013).

laparoscopic endometrioma excision

Intervention Type PROCEDURE

Interventions

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laparoscopic endometrioma excision

Intervention Type PROCEDURE

Conservative follow up

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Reproductive age
* Endometrioma without indication for surgery or treatment with combined contraceptive, progestin or other hormonal intervention.

Exclusion Criteria

* Menstrual cycle irregularity
* Polycystic ovarian syndrome
* Women who were pregnant or contemplating pregnancy in the next six months
* History of ovarian surgery
* Using medication which could affect ovarian function during six months before recruitment
* Indication for surgical excision
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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GÜRKAN UNCU,PROF. MD

prof.md

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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gürkan uncu

Role: STUDY_DIRECTOR

Uludag University School of Medicine

Locations

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Uludag University Scholl of medicine

Bursa, Turkey/bursa, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Uncu G, Kasapoglu I, Ozerkan K, Seyhan A, Oral Yilmaztepe A, Ata B. Prospective assessment of the impact of endometriomas and their removal on ovarian reserve and determinants of the rate of decline in ovarian reserve. Hum Reprod. 2013 Aug;28(8):2140-5. doi: 10.1093/humrep/det123. Epub 2013 Apr 26.

Reference Type BACKGROUND
PMID: 23624580 (View on PubMed)

Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.

Reference Type DERIVED
PMID: 29935810 (View on PubMed)

Other Identifiers

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2015-7/12

Identifier Type: -

Identifier Source: org_study_id