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| Name | Class |
|---|---|
| Wish Fertility Hospital Pvt. Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Mitochondria transfer | Active Comparator | Mitochondria isolated from autologous adipose-derived stem cells are transplanted into the oocyte in conjunction with intracytoplasmic sperm injection (ICSI); Mito-ICSI group |
|
| Conventonal Intracytoplasmic Sperm Injection | No Intervention | Conventional ICSI; Control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Embryo development rate | Analyze and compare the transferable embryo rate per zygote on day 3 & day 5 between the Intervention and control groups. | Up to 8 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing clinical pregnancy rate after the first transfer | Compare ongoing clinical pregnancy rates between the intervention and conrolgroups | Up to 18 months post-intervention |
| Chemical pregnancy rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. SANATHUDAYANGA KANKANAMGAMAGE, PhD | Contact | +818014361766 | udayanga646@ivfjapan.com | |
| Dr. HELARUWAN PASAN KUMARA WA, MD, PhD | Contact | +94 77 327 3866, +9477 478 878 | helaruwanpasankumara@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Helaruwan Pasan Kumara WA, MD, PhD | Wish Fertility Hospital Pvt. Ltd | Principal Investigator |
| Prof. Yoshiharu Morimoto, MD, PhD | Horac Grand Front Osaka Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wish Fertility Hospital Pvt. Ltd | Recruiting | Colombo | Sri Lanka |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35883564 | Result | 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. | |
| 38777961 | Result | 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. |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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This is a triple-blind (Patient, Embryologist, Doctor), single-center, randomized, controlled experimental pilot study.
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Compare the chemical pregnancy rates between the two groups.
| Up to 18 months post-intervention |
| Live Birth rates | Compare live Birth rate following the intervention in both groups | Up to 24 months post-intervention |
| Pregnancy complication | Rate of pregnancy complication in both groups | Up to 24 months post-intervention |
| Abortion rate | Compare the abortion rates in both groups | Up to 24 months post-intervention |
| Additional in vitro fertilization - outcome indicators | Compare the rate of fertilization in between two groups | Up to 8 weeks post-intervention |
| Additional in vitro fertilization - outcome indicators | Rate of abnormal fertilization in both groups | Up to 8 weeks post-intervention |
| Additional in vitro fertilization - outcome indicators | The rate of non-transferable embryos in both groups | Up to 8 weeks post-intervention |
| 36769061 | Result | 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. |
| D000091662 | Genital Diseases |
| D007246 | Infertility |