Assessment of the New Automated Vitrification System "GAVI" for Early Cleaved Embryos Cryopreservation (GAVI)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Toulouse、フランス、31059
- Hospital University of Toulouse
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Implantation rate of frozen/thawed embryos
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of intact blastomeres after thawing
時間枠：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.
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Roger Léandri, MD、University Hospital, Toulouse
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- RC31/16/8766
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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reference techniqueの臨床試験
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Luzerner Kantonsspital完了
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate...完了