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Table 2 In progress clinical trials about AUGMENT treatment around the world

From: Autologous mitochondrial microinjection; a strategy to improve the oocyte quality and subsequent reproductive outcome during aging

Title and 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