HELIOS Advanced: Human Embryo Illumination to Enhance Development (HELIOS-A)
HELIOSアドバンスト：ヒト卵母細胞の照明による発育促進
As women get older, the "power plants" of the cells (called mitochondria) don't work as well. This makes it harder for eggs and embryos to develop normally. One possible way to help is with a gentle light treatment called photobiomodulation (PBM). This uses a special type of red light that boosts energy production in cells and helps them stay healthy. This study will test whether adding this light treatment during in vitro fertilization (IVF) can improve embryo growth and pregnancy outcomes.
調査の概要
詳細な説明
Embryo development is highly energy-dependent, and impaired mitochondrial function is a well-established hallmark of reproductive aging. As women age, reactive oxygen species (ROS) accumulate and cause mitochondrial DNA (mtDNA) damage, leading to reduced oxidative phosphorylation, ATP (Adenosine 5'-triphosphate) depletion, and developmental arrest of embryos. Enhancing mitochondrial function represents a promising strategy to improve embryo quality, particularly in women of advanced maternal age.
Photobiomodulation (PBM), also known as low-level light therapy (LLLT), involves the application of low-intensity red or near-infrared (NIR) light to modulate mitochondrial activity. NIR light specifically activates cytochrome c oxidase, leading to increased ATP production, reduced oxidative stress, and improved cellular resilience. Numerous preclinical studies, including isolated mitochondria, cell cultures, and in vivo animal models, have confirmed the safety and efficacy of NIR light in restoring mitochondrial function without inducing DNA damage or chromosomal abnormalities.
The investigators previously conducted IRB-approved laboratory studies using mouse and donated human embryos, demonstrating that brief exposure to PBM improved blastocyst formation without adversely affecting chromosomal status.
The current study builds upon this foundational work to evaluate the clinical impact of PBM at the oocyte stage. In a randomized, blinded, sibling-embryo design, the investigators will test whether PBM improves fertilization rates, blastocyst formation, embryo quality, and pregnancy outcomes in participants undergoing IVF or ICSI (Intracytoplasmic sperm injection) with PGT-A (preimplantation genetic testing for aneuploidy) using their autologous oocytes.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Samuel Zev Williams, MD, PhD
- 電話番号：646-756-8282
- メール：zw2421@cumc.columbia.edu
研究場所
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New York
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New York、New York、アメリカ、10019
- 募集
- Columbia University Fertility Center
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主任研究者：
- Samuel Z Williams, MD, PhD
-
コンタクト：
- Stephanie Morgan, MS
- 電話番号：646-756-8282
- メール：sm3415@cumc.columbia.edu
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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:
- Female age between 18-48 years at the time of the IVF/ICSI cycle
- Undergoing blastocyst culture
- Using own oocytes
- Has at least two cleavage stage embryos available for randomization on Day 3 of embryo development
- Consenting to embryo level randomization
- Plan to transfer euploid embryo within 6 months
Exclusion Criteria:
- Use of donor oocytes or gestational carrier
- Concurrent experimental laboratory inventions outside of protocol
- Refusal of randomization or request for non-standard handling
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：No photobiomodulation
Participants will receive the same treatment (IVF/ICSI cycles with PGT-A). Participant's resultant cleavage stage embryos will be randomized to not receive PBM. |
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実験的：Photobiomodulation
Participants will receive the same treatment (IVF/ICSI cycles with PGT-A). Participant's resultant cleavage stage embryos will be randomized to receive PBM. |
Photobiomodulation (PBM): also known as low-level light therapy (LLLT), involves the application of low-intensity red or near-infrared (NIR) light to modulate mitochondrial activity. |
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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Number of usable blastocysts
時間枠：Seven days post egg retrieval
|
Usable blastocysts are defined as blastocysts that can be biopsied and frozen on Day 5, 6, or 7 of development for PGT-A (pre-implantation genetic testing for aneuploidy). The study will calculate the usable blastocyst rate per oocyte retrieved defined as the number of usable blastocysts per cleavage stage embryo on Day 3. |
Seven days post egg retrieval
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to 2-cell stage
時間枠：Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the 2-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Time to 3-cell stage
時間枠：Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the 3-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
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Time to 6-cell stage
時間枠：Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the 6-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Time to 8-cell stage
時間枠：Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the 8-cell stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
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Time to morula
時間枠：Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the morula stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
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Time to start of blastulation
時間枠：Up to seven days post egg retrieval
|
Time (hours) for embryo to start blastulation from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Time to blastocyst
時間枠：Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the blastocyst stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
|
|
Time to hatching blastocyst
時間枠：Up to seven days post egg retrieval
|
Time (hours) for embryo to reach the hatching blastocyst stage from insemination/ICSI as assessed by embryology using time-lapse imaging. |
Up to seven days post egg retrieval
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Number of good quality blastocysts as defined by Gardner grading system
時間枠：Up to seven days post egg retrieval
|
Final blastocyst quality at the time of cryopreservation (Day 5,6, or 7) will be assessed using the Gardner grading system, which consists of three parameters: expansion and hatching status (graded 1-6), inner cell mass (graded A-D), and trophectoderm (graded A-D). A good quality blastocyst will be defined as a blastocyst of grade 3BB or higher. |
Up to seven days post egg retrieval
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Euploidy Rate
時間枠：Within 30 days post egg retrieval
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The chromosomal ploidy status of cryopreserved blastocysts is assessed by the presence of two copies of each autosome and the expected complement of sex chromosomes. The euploidy rate is defined as the number of cryopreserved blastocysts that have the correct number of chromosomes divided by the total number of cryopreserved blastocysts. |
Within 30 days post egg retrieval
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Proportion of Embryo Selected for Transfer
時間枠：Within 1 year post egg retrieval
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In cases with no stated embryo sex preference, the proportion of cycles in which the embryo selected for transfer is from the PBM-treated group versus the control group will be reported. |
Within 1 year post egg retrieval
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Implantation Rate
時間枠：Within 1 year post egg retrieval
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Implantation rate is defined as the number of cycles with positive beta hCG (human chorionic gonadotropin) nine days or more post frozen embryo transfer divided by the total number of frozen embryo transfer cycles. |
Within 1 year post egg retrieval
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Clinical pregnancy rate
時間枠：Within 1 year post egg retrieval
|
Clinical pregnancy rate is defined as the number of cycles with the presence of a gestational sac visualized on transvaginal ultrasound divided by the total number of frozen embryo transfer cycles. |
Within 1 year post egg retrieval
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Miscarriage rate
時間枠：Within 1 year of egg retrieval
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Miscarriage rate is defined as the number of cycles with clinical pregnancy losses divided by the number of cycles that had positive hCGs post frozen embryo transfer. |
Within 1 year of egg retrieval
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Live birth rate
時間枠：Up to 2 years post egg retrieval
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Live birth rate is defined as the number of cycles with a live born infant after 24 weeks gestation divided by total number of frozen embryo transfer cycles. |
Up to 2 years post egg retrieval
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Gestational Age at Delivery
時間枠：Up to 2 years post egg retrieval
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Total number of completed weeks and days of pregnancy, calculated using frozen embryo transfer date. |
Up to 2 years post egg retrieval
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Birthweight
時間枠：Up to 2 years post egg retrieval
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The weight of the baby at birth in grams |
Up to 2 years post egg retrieval
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Samuel Zev Williams, MD/PhD、Columbia University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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