Table 2 In progress clinical trials about AUGMENT treatment around the world
Title and ClinicalTrials.gov identifier | Interventions and conditions | Primary outcome measures | Secondary outcome measures | Inclusion criteria | Sponsor | The last update posted | Phase | Status |
|---|---|---|---|---|---|---|---|---|
Clinical application of autologous mitochondria transplantation for improving oocyte quality NTC number: NCT03639506 | Procedure: autologous mitochondria transplantation combination Product: autologous mitochondria from BMSCs into oocyte as well as ICSI Condition(s): repetition failure | The rate of live birth | Retrieved oocytes number Fertility rate Clinical pregnancy rate Good quality embryo rate normal fertility rate | Inclusion criteria  Women age 20–43 years  AMH (level ≥ 1.1 ng/mL)  BMI: 18–25 kg/m2  Previous failed transfer cycles ≥ 2  Written informed consent Exclusion criteria  Abnormal uterine development, endometrial adhesion or previous endometrial dysplasia  Other medical diseases that cannot be pregnant  Complicated with malignant tumors or precancerous disease, endometriosis  Untreated hydrosalpinx  The man has definite factors that affect the quality of the embryo, such as non-obstructive spermatozoa and persistent abnormal DNA fragment rate (> 30%)  ICSI with donor Eliminate or falls off criteria  The number of retrieved oocytes < 6 | Sun Yat-sen University | August 2018 | – | Not yet recruiting |
Autologous mitochondrial transfer in ICSI to improve oocyte and embryo quality in IVF patients. Pilot study NTC number: NCT02586298 | Autologous mitochondria with ICSI Condition(s): infertility | Ongoing pregnancy rate | – | Inclusion criteria  BMI < 30  Age ≤ 42 years  Previous IVF cycle with 5 or more metaphase II oocytes after retrieval  Serum AMH ≥ 4 pM/L  Will undergo an IVF cycle with arrays in preimplantation genetic screening  Semen sample with concentrations exceeding 3 million/mL progressive motile sperm  All cases without embryo transfer due to the presence of a blockage of embryo development before D3 in embryos  All cases without embryo transfer due to any chromosomal abnormality detected by PGD or PGS techniques  A history of previous cycles of IVF with embryo transfer and without pregnancy due to low embryo quality Exclusion criteria  Severe male factor  Formal contraindication in ovarian cortex biopsy or follicle puncture  Any characteristic incompatible with carrying out a new IVF cycle at IVI Valencia | IVI VALENCIA, Spain | August 2017 | – | Completed |
Improving the reproductive outcome of poor quality ova by injection of autologous somatic mitochondria NTC number: NCT01631578 | Injection of autologous mitochondria into the oocytes Condition(s): low ovarian reserve and poor quality oocytes | Oocyte fertilization rate The quality of early embryonic development | Clinical pregnancy | Inclusion criteria  Adequate sperm source  Adequate uterine cavity  And one or more of the following: 3 unsuccessful IVF cycles or > 75% of embryos with < 50% fertilization rate or > 20–50% fragments in previous cycles  Age > 40 Exclusion criteria  Inadequate sperm source  Inadequate uterine cavity | Hadassah medical organization | August 2015 | 1 2 | Withdrawn |