Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)

Официальное название

Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients With Recurrent Pregnancy Failure

Обзор

The purpose of this study is to investigate the potential of autologous adipose stem cell (ASC) mitochondrial transfer (ASCENT) to oocytes along with intracytoplasmic sperm injection (ICSI)as a means of enhancing embryo development and improving the success rate of in patients with a history of multiple IVF failures. Embryo quality plays a crucial role in determining the success of assisted reproductive technologies and directly contributes to repeated pregnancy failures. Several factors, including age, physiological conditions, genetics, and environmental influences, can significantly impact embryo quality. Oocytes, the largest cells in the human body, are heavily reliant on mitochondria. Mitochondria's role in providing energy for oocytes is crucial, and insufficient energy production has been linked to poor oocyte and embryo quality. Some human studies have shown that increasing oocyte mitochondrial mass can improve embryo quality in patients who have experienced repeated IVF failures.

Подробное описание

Sibling mature oocytes will be randomly divided into two groups. And one group of oocytes will be undergone conventional intracytoplasmic sperm injection (ICSI) (control group; cont. ICSI) and the other group of oocytes will be undergone mitochondria transplantation along with intracytoplasmic sperm injection (Mito-ICSI). Viable blastocysts from both groups will be biopsied for preimplantation genetic testing for aneuploidy.

Вмешательства

• Другое Experimental
  Autologous adipose stem cell mitochondrial transfer to mature oocytes along with intracytoplasmic sperm injection (ICSI). The intervention is also termed as Adipose Stem Cell ENergy Transfer (ASCENT).

Первичные конечные точки

• Embryo development rate [Срок оценки: Up to 8 weeks post-intervention]

Вторичные конечные точки (8)

• Ongoing clinical pregnancy rate after the first transfer [Срок оценки: Up to 18 months post-intervention]
• Chemical pregnancy rate [Срок оценки: Up to 18 months post-intervention]
• Live Birth rates [Срок оценки: Up to 24 months post-intervention]
• Pregnancy complication [Срок оценки: Up to 24 months post-intervention]
• Abortion rate [Срок оценки: Up to 24 months post-intervention]
• Additional in vitro fertilization - outcome indicators [Срок оценки: Up to 8 weeks post-intervention]
• Additional in vitro fertilization - outcome indicators [Срок оценки: Up to 8 weeks post-intervention]
• Additional in vitro fertilization - outcome indicators [Срок оценки: Up to 8 weeks post-intervention]

Критерии участия

Критерии включения

• Having at least three previous failed IVF trial
• Specifically consented for to collect biopsies for Preimplantation generic testing for aneuploidy (PGTA) analysis
• Specifically consented for to have single blastocyst transfer (recommended)
• No major uterine or ovarian abnormalities
• Specifically consented for to have all embryos frozen
• Specifically consented for to collect adipose tissues from subcutaneous liposuction
• BMI level level <26kg/m2

Критерии исключения

• Ovarian endometriosis with Chocolate cysts (American Fertility Society (AFS)) classification type 3 and 4
• Any medical contraindication oocyte retrieval or subsequent procedures Ovarian hyperstimulation syndrome Bleeding disorders Sex hormone allergies Severe emotional defect on injections
• Severe sperm abnormalities
• <5 million/mL motile sperm
• Uterine structural anomalies
• Polycystic ovaries
• Premature ovarian failure

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Sri Lanka · 1 центр

• Wish Fertility Hospital Pvt. Ltd — Colombo

Публикации

• Kankanam Gamage US, Hashimoto S, Miyamoto Y, Nakano T, Yamanaka M, Koike A, Satoh M, Morimoto Y. Mitochondria Transfer from Adipose Stem Cells Improves the Developmental Potential of Cryopreserved Oocytes. Biomolecules. 2022 Jul 21;12(7):1008. doi: 10.3390/biom12071008. PMID 35883564
• Kankanam Gamage SU, Hashimoto S, Miyamoto Y, Nakano T, Yamanaka M, Kitaji H, Takada Y, Matsumoto H, Koike A, Satoh M, Ichishi M, Watanabe M, Morimoto Y. Supplementation with autologous adipose stem cell-derived mitochondria can be a safe and promising strategy for improving oocyte quality. J Assist Reprod Genet. 2024 Aug;41(8):2065-2077. doi: 10.1007/s10815-024-03137-2. Epub 2024 May 22. PMID 38777961
• Morimoto Y, Gamage USK, Yamochi T, Saeki N, Morimoto N, Yamanaka M, Koike A, Miyamoto Y, Tanaka K, Fukuda A, Hashimoto S, Yanagimachi R. Mitochondrial Transfer into Human Oocytes Improved Embryo Quality and Clinical Outcomes in Recurrent Pregnancy Failure Cases. Int J Mol Sci. 2023 Feb 1;24(3):2738. doi: 10.3390/ijms24032738. PMID 36769061

Идентификаторы

NCT: NCT07066267 · WishREC/24-011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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