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
Conditions
Interventions
Patients who have failed 3 or more traditional IVF cycles begin with standard, non-investigational IVF stimulation, followed by retrieval and cryopreservation of germinal vesicle (GV) oocytes or matur
Sponsors
Darwin Life, INC
Clinic of reproductive medicine NADIYA LLC
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. No regular menstrual cycle 2. Poor ovarian reserve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blastocyst rate measured using a noninvasive timelapse imaging system on Day 5 – Day 7 post insemination 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 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 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 2. Fertilization rates measured using a noninvasive timelapse imaging system at 17 ±1 hours post ICSI 3. Miscarriage rates calculated from the total number of patients scored as pregnant based on the primary outcome measure point #3 | — |
Countries
Ukraine
Outcome results
None listed