Home » Trials » SLCTR/2025/042
Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients with Recurrent Pregnancy Failure
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SLCTR Registration Number
SLCTR/2025/042
Date of Registration
The date of last modification
Nov 06, 2025
Scientific Title of Trial
Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients with Recurrent Pregnancy Failure
Public Title of Trial
Pilot randomized controlled trial of autologous adipose stem cell-derived mitochondria transplantation to oocytes versus standard Intracytoplasmic Sperm Injection (ICSI) for improving embryo quality in women with recurrent pregnancy failure.
Disease or Health Condition(s) Studied
Female Infertility
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1323-4828
Any other number(s) assigned to the trial and issuing authority
REC/24-011; RESERCH ETHICS COMMITTEE SRI LANKA MEDICAL ASSOCIATION
What is the research question being addressed?
Does autologous transfer of mitochondria derived from adipose stem cells into oocytes enhance oocyte quality and subsequent embryo development compared to standard intracytoplasmic sperm injection in patients with repeated IVF failure?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Data analysts, Healthcare providers
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 0 (exploratory trials)
Intervention(s) planned
Study setting: The trial is conducted at Embryology laboratory at Wish Fertility Hospital under standard QA/QC protocols.
Method of randomization: In this pilot trial, randomization is performed at the oocyte level within each stimulation cycle. Sibling MII oocytes from the same patient are allocated as evenly as possible (approximately 1:1 ratio) between the intervention (Mito-ICSI) and control (standard ICSI) groups. Allocation is performed manually according to a pre-defined randomization schedule.
Intervention: Sibling MII oocytes will be randomly allocated to experimental (Mito-ICSI) or intracytoplasmic sperm injection (ICSI). Autologous mitochondria are isolated from patient’s adipose-derived stem cells under standard operating procedure (SOP) conditions. Co-injection is performed during ICSI with ~2-5 pL (according to diameter and length of injecting pipet) suspension per oocyte; control arm receives identical ICSI without mitochondria. Viable blastocysts from both groups will be biopsied for preimplantation genetic testing for aneuploidy.
Embryos from both arms may be generated. Transfer will follow standard morphology/kinetics and/or Preimplantation Genetic Testing for Aneuploidies (PGT-A) criteria, blinded to allocation. PGT-A allows retrospective tracking of embryo origin (Mito-ICSI vs control) for analysis.
Inclusion criteria
o Agree to participate to the study o 27-39 years old o Having at least three previous failed IVF trial o Agree to collect biopsies for Preimplantation Genetic Testing for Aneuploidy (PGTA) analysis o Agree to have single blastocyst transfer (recommended) o No major uterine or ovarian abnormalities o Agree to have all embryos frozen o Agree to collect adipose tissues from subcutaneous liposuction o BMI level level <26kg/m2
Exclusion criteria
o Ovarian endometriosis with Chocolate cysts (American Fertility Society-AFS type 3 and 4 ) o Any medical contraindication oocyte retrieval or subsequent procedures o Severe sperm abnormalities o <5 million/mL motile sperm o Uterine structural anomalies o Polycystic ovaries o Premature ovarian failure
Primary outcome(s)
|
1.
Transferable embryo rate per zygote on day 3 Rate of blastocyst development on day 5 and 6. Day 3 embryos are evaluated using Veeck’s morphological criteria to determine quality and transferability. Day 5-6 blastocysts are assessed using the Gardner grading system for expansion, inner cell mass, and trophectoderm quality. Furthermore, all embryos are cultured in a time-lapse incubator, which provides morphokinetic data and an additional objective scoring system. These combined assessments are standard practice in ART laboratories and provide validated outcome measures for embryo quality. |
[ Day 3 and Day 5 after interventions ] |
Secondary outcome(s)
|
1.
Post-transfer: Biochemical pregnancy confirmed by serum beta-hCG. |
[ 2 weeks post transfer ] |
|
2.
Clinical pregnancy confirmed by the presence of a gestational sac and fetal heartbeat. |
[ ~6-7 weeks post transfer ] |
|
3.
Ongoing pregnancy defined by a viable pregnancy beyond the first trimester. |
[ ~12 weeks post transfer ] |
|
4.
Live birth rate |
[ At term (40 weeks) ] |
Target number/sample size
20 in each arm (A total of 20 patient’s oocytes will be allocated to each arm, with all retrieved oocytes evenly divided into two groups for the study))
Countries of recruitment
Sri Lanka
Anticipated start date
2025-11-07
Anticipated end date
2026-12-31
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2025-05-19
Approval number
REC/24-011
Details of Ethics Review Committee
| Name: | Reaserch Ethics Commitee of the Sri Lanka Medical Association |
| Institutional Address: | No. 6, Wijerama Road, Colombo 7 |
| Telephone: | Telephone: +94 (11) 2693 324 |
| Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Helaruwan Pasan Kumara
Chairman
30 Elhena Rd, Maharagama 10230, Sri Lanka
+94 77 791 0910
+94 77 478 8788
wishiuiivf@gmail.com
https://www.wishfertility.lk/
Contact Person for Public Queries
Udayanga Sanath Kankanam Gamage
Senior Research Fellow
530-0011 Japan, Osaka, Kita Ward, Ofukacho, 3-1, 15F
08014361766
+818014361766
udayanga646@ivfjapan.com
https://www.ivfhorac.com/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
