- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02792569
Follicle Activation by Inhibition of the Hippo Pathway
Auto-transplantation of Fragmented Ovarian Cortical Tissue in Infertile Patients With Premature Ovarian Oocyte Depletion - a Study to Promote Follicular Activation and Subsequent Fertility
연구 개요
상세 설명
For this study investigators will carefully select 20 women with low AMH and imminent POI.
They will be randomized to have cortical ovarian biopsies taken from either the left or right ovary. The biopsies will be fragmented in 1x1 mm2 pieces and immediately auto-transplanted in a peritoneal pocket under the right ovary.
The contralateral untouched ovary will act as the control, making each woman their own control.
Follow up: each week in 2,5 months the women will be assessed by transvaginal ultrasound and hormonal status. After 2,5-6 months the women will receive a FSH stimulation cycle (rFSH 300 IU or Corifollitropin) followed by standard IVF/ICSI,
Hypothesis: the ovaries contain a pool of resting primordial follicles. By fragmentation of cortical ovarian tissue, manipulation of the local environment in the tissue will inhibit the Hippo Pathway and hereby active recruitment and growth of primordial follicles.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Copenhagen, 덴마크, 2100
- The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Infertility with indication for IVF/ICSI
- Imminent POI, still cycling
- Age 25 - 39 years
- Two ovaries
- Serum AMH measurements < 5 pmol/l (two independent measurements)
- Antral follicle count (AFC) (sum of both ovaries < 5)
Exclusion Criteria:
- Ovarian pathology (endometriosis, cysts)
- Known chromosomal abnormality
- Known autoimmune disease (except TPO-antibodies)
- Patients who have contraindication for laparoscopy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Biopsy at Right side
Biopsy of ovarian cortical tissue (50% right side)
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Biopsies will be taken from either right or left side.
The cortical tissue will be isolated and fragmented in 1x1 mm2 pieces, followed by auto-transplantation to a peritoneal pocket.
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실험적: Biopsy at Left side
Biopsy of ovarian cortical tissue (50% left side)
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Biopsies will be taken from either right or left side.
The cortical tissue will be isolated and fragmented in 1x1 mm2 pieces, followed by auto-transplantation to a peritoneal pocket.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of follicles > 12 mm
기간: Up to 6 month after the auto-transplantation
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Number of follicles > 12 mm in response to controlled ovarian stimulation with corifollitropin from the biopsied ovary versus the contralateral untreated ovary
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Up to 6 month after the auto-transplantation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Side of ovulation
기간: Up to 6 months after auto-transplantation
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Frequency of ovulations occurring at the "biopsy side" versus the contralateral side in the subsequent 4- 6 months
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Up to 6 months after auto-transplantation
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
AFC count
기간: Up to 10 month after auto-transplantation
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Number of antral follicles (AFC) at the biopsy side versus that of the contralateral side
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Up to 10 month after auto-transplantation
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AMH changes
기간: Up up to 10 month after auto-transplantation
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Changes (increase - decrease) in serum AMH over time, using the highly sensitive new AMH Assay (Elecsys Assay; Roche), which has been implemented as a routine analysis at The Department of Clinical Biochemistry Rigshospitalet in June 1st 2015
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Up up to 10 month after auto-transplantation
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Pregnancy
기간: Through study completion, an average of 1 year
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Numbers of pregnancies (spontaneously/assisted)
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Through study completion, an average of 1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Anders N Andersen, Professor, Rigshospitalet, Denmark
간행물 및 유용한 링크
일반 간행물
- Kawamura K, Cheng Y, Suzuki N, Deguchi M, Sato Y, Takae S, Ho CH, Kawamura N, Tamura M, Hashimoto S, Sugishita Y, Morimoto Y, Hosoi Y, Yoshioka N, Ishizuka B, Hsueh AJ. Hippo signaling disruption and Akt stimulation of ovarian follicles for infertility treatment. Proc Natl Acad Sci U S A. 2013 Oct 22;110(43):17474-9. doi: 10.1073/pnas.1312830110. Epub 2013 Sep 30.
- Suzuki N, Yoshioka N, Takae S, Sugishita Y, Tamura M, Hashimoto S, Morimoto Y, Kawamura K. Successful fertility preservation following ovarian tissue vitrification in patients with primary ovarian insufficiency. Hum Reprod. 2015 Mar;30(3):608-15. doi: 10.1093/humrep/deu353. Epub 2015 Jan 6.
- Hsueh AJ, Kawamura K, Cheng Y, Fauser BC. Intraovarian control of early folliculogenesis. Endocr Rev. 2015 Feb;36(1):1-24. doi: 10.1210/er.2014-1020. Epub 2014 Sep 9.
- Lunding SA, Pors SE, Kristensen SG, Landersoe SK, Jeppesen JV, Flachs EM, Pinborg A, Macklon KT, Pedersen AT, Andersen CY, Andersen AN. Biopsying, fragmentation and autotransplantation of fresh ovarian cortical tissue in infertile women with diminished ovarian reserve. Hum Reprod. 2019 Oct 2;34(10):1924-1936. doi: 10.1093/humrep/dez152.
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- H-15011975
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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