- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02438735
Endometrioma Related Reduced Ovarian Reserve (ERROR)
The Effect Of The Presence Of Endometriomas On Ovarian Reserve
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Turkey/bursa
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Bursa, Turkey/bursa, Turkey
- Uludag University Scholl of medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The decision to include a healthy control group was taken five months after starting recruitment of women with endometrioma. Only 12 women with endometriomas had been recruited until then and none of them had six month serum AMH level measured.
Since healthy controls were reluctant to undergo transvaginal ultrasound examination, antral follicle counts were not measured as another marker of ovarian reserve for healthy controls and some women in the endometrioma group.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Endometrioma
Reproductive aged women diagnosed with endometrioma.
Conservative follow up for six months.
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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. |
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Serum Anti- mullerian hormone (AMH) level
Time Frame: at recruitment and six months later
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at recruitment and six months later
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: gürkan uncu, Uludag University School of Medicine
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-7/12
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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