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.

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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2025/042

Enrollment

Unknown

Registered

2025-11-06

Start date

2025-11-07

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility

Interventions

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 t

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 gener

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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]	—

Measure

Time frame

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

Measure	Time frame
Post-transfer: Biochemical pregnancy confirmed by serum beta-hCG. [2 weeks post transfer] Clinical pregnancy confirmed by the presence of a gestational sac and fetal heartbeat. [ ~6-7 weeks post transfer ] Ongoing pregnancy defined by a viable pregnancy beyond the first trimester. [~12 weeks post transfer] Live birth rate [ At term (40 weeks)]	—

Countries

Sri Lanka

Contacts

Public ContactDr. Helaruwan Pasan Kumara

Chairman

wishiuiivf@gmail.com+94 77 791 0910

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Sep 19, 2026