Clinical trial for the treatment of infertility due to poor oocyte quality
- Conditions
- Infertility which cannot be successfully treated via traditional IVF: infertility due to oocyte maturation arrest, embryo cleavage arrest before blastulation, mitochondrial mutation (ie 8993T > G), tubulin mutation (ie TUBB8), or absence of euploid embryos.Pregnancy and Childbirth
- Registration Number
- ISRCTN13358803
- Lead Sponsor
- Darwin Life, INC
- Brief Summary
1. Zhang, J., et al., Live birth derived from oocyte spindle transfer to prevent mitochondrial disease. Reprod Biomed Online, 2017. 34(4): p. 361-368. 2. Zhang, J., et al., In vitro maturation of human preovulatory oocytes reconstructed by germinal vesicle transfer. Fertil Steril, 1999. 71(4): p. 726-31. 3. Liu, H. et al., In vitro development of human oocytes reconstructed by sequential transfer of germinal vesicle and MII spindle. Fertility and Sterility, Volume 108, Issue 3, e57 - e58 4 Wang X., et al., Novel mutations in genes encoding subcortical maternal complex proteins may cause human embryonic developmental arrest. Reproductive biomedicine online. – 2018. – Vol 36 – N6. – P698-704 5. Narravula A., et al., Three parent baby – Prenatal genetic confirmation of the outcome of mitochondrial replacement therapy. ACMG Annual Meeting – March 2017. – 2017. – AN750. 6. Mazur P., et al., Reverse reconstitution of human zygotes reveals the competence of zygotic cytoplasts in women of advanced maternal age. RBM online. – 2019. – Vol. 38, Supl. 1. – e32-e33. 7. Mykytenko D., et al., Efficacy of nuclear transfer to prevent the inherited mitochondrial pathology. REBM online. – 2019. – Vol 39., Supl. 1. – P. e60.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 100
Group 1: 41 years old or older, having failed three or more IVF cycles, and still has a regular menstrual cycle. Group 2: 40 years old or younger AND with regular menstrual period AND having failed three or more IVF cycles, OR carrier of Mitochondrial DNA Disease OR a history of failure to form blastocysts.
1. No regular menstrual cycle
2. Poor ovarian reserve
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Blastocyst rate measured using a noninvasive timelapse imaging system on Day 5 – Day 7 post insemination<br> 2. Euploidy rate measured via array-based comparative genomic hybridization (aCGH) or next generation sequencing (NGS) analysis of trophectoderm biopsy from embryos on Day 5 – Day 7 post insemination<br> 3. Clinical pregnancy rate as measured by rising beta hCG levels starting at 7 days post embryo transfer, presence of gestational sac at 6-7 weeks post embryo transfer, and presence of fetal heartbeat at 6-7 weeks post embryo transfer<br> 4. Health of baby at birth and long term follow up. In specific, a pediatrician will examine the child on a yearly basis for the first 7 years, and then on a bi-yearly basis until age 18. This includes periodic completion of a Quality of Life questionnaire related to the offspring produced in the clinical trial<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Germinal vesicle maturation rates measured using morphological observations at 24, 30 and/or 48 hours post commencement of in vitro maturation (IVM). At each time point during IVM the germinal vesicle oocytes will be scored for maturation via (i) brightfield microscope observations for the extrusion of the first polar body and (ii) polarized light microscope observations for the formation of the metaphase II birefringent spindle<br> 2. Fertilization rates measured using a noninvasive timelapse imaging system at 17 ±1 hours post ICSI<br> 3. Miscarriage rates calculated from the total number of patients scored as pregnant based on the primary outcome measure point #3<br>