Assessment of the New Automated Vitrification System "GAVI" for Early Cleaved Embryos Cryopreservation (GAVI)
연구 개요
상세 설명
The last decade has seen a development of a new cryopreservation technique called vitrification. Despite a lack of randomized control trials comparing slow-freezing and vitrification, vitrification seems to show better recovery rates and pregnancy outcomes. However vitrification is a manual, labour-intensive and highly skilled procedure, results can vary between embryologists and clinics. The GAVI system, an automation instrument with a novel closed system device has been developed. The present study would like to assess the outcomes for embryos automatically vitrification processed with the GAVI system compared with those processed with conventional reference technique of slow freezing.
The meta-analysis comparing the cryopreservation of human embryos by vitrification or slow-freezing suggested that more well design studies as randomized trials are necessary to identify the most successful method for cryopreservation. The efficacy of the vitrification with the GAVI system will be compared with the conventional slow freezing method through a randomized control trial. Couples in IVF attempt will be randomized at the day of embryo cryopreservation by the biologist. Supernumerary frozen embryos will be thawed and transferred in utero in case of failure of the "fresh" embryo transfer. The outcomes of the thawing and frozen/thawed embryo transfer will be assessed. In the two groups, the patients will benefit of the standard IVF procedures applied in the Assisted Reproductive Technologies center of Toulouse.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Toulouse, 프랑스, 31059
- Hospital University of Toulouse
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Couple whose age is > 18 years and who are included in a IVF procedure with the possibility to cryopreserve embryos according to criteria applied at the hospital of Toulouse
- Signed informed consent by both partners in a couple
- Affiliation to a social security scheme for both partners of the couple
Exclusion Criteria:
- Couples who does not meet current requirements described by the bioethics law for accession to the ART procedure
- Positive plasma viral load for HIV, hepatitis C virus or hepatitis B virus during the year before the inclusion in one of the couple.
- One of the two partners (or both) is (are) in safeguarding justice, under guardianship or trusteeship.
- Couple included in another interventional study.
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 |
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실험적: reference technique slow freezing
In reference technique slow freezing arm, embryon will be frozen with the conventional slow freezing procedure with the Freezal device apply a slow decreasing in temperature with moderate cryoprotector concentration
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Slow-freezing procedure is the reference technique, actually use at the Toulouse hospital, to cryopreserve embryos.
Embryon are frozen with a slow freezing.
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실험적: vitrification technique
In vitrification technique arm, embryon will be frozen with automated vitrification system
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Vitrification is the new technique to freeze embryons.
In this study, the GAVI system will be use for for embryos automatically vitrification
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Implantation rate of frozen/thawed embryos
기간: 1 month
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The number of implantation embryo with cardiac activity in reference technique and in vitrification technic
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1 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of intact blastomeres after thawing
기간: 1 month
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It will be measured by microscopic evaluation by a biologist or an IVF laboratory technician at the time of thawing, routine very simple laboratory to do because at this early embryonic stage there are few cells: 4 to 8 cells and they are well individualized.
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1 month
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Implantation rate of transferred embryos.
기간: 1 month
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number of implantation of transferred embryos in both technique
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1 month
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Live birth rates
기간: 9 months after the implantation
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Number of live birth for reference technique and for vitrification technique
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9 months after the implantation
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공동 작업자 및 조사자
수사관
- 수석 연구원: Roger Léandri, MD, University Hospital, Toulouse
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RC31/16/8766
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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불임 장애에 대한 임상 시험
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Jordi Zaragoza아직 모집하지 않음
reference technique에 대한 임상 시험
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Atlas University아직 모집하지 않음
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dr. Muhammad Abdelhafez Mahmoud, MD완전한
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Simcere Pharmaceutical Co., Ltd아직 모집하지 않음