- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02438735
Endometrioma Related Reduced Ovarian Reserve (ERROR)
The Effect Of The Presence Of Endometriomas On Ovarian Reserve
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Turkey/bursa
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Bursa, Turkey/bursa, 칠면조
- Uludag University Scholl of medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Change in Serum Anti- mullerian hormone (AMH) level
기간: at recruitment and six months later
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at recruitment and six months later
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공동 작업자 및 조사자
수사관
- 연구 책임자: gürkan uncu, Uludag University School of Medicine
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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