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. 2020 Jul 16;2020(7):CD013497. doi: 10.1002/14651858.CD013497.pub2

NCT01689428.

Methods Prospective randomised controlled trial
Participants 100 infertile couples with an indication for standard IVF or intracytoplasmic sperm injection. All couples had at least a previous miscarriage and/or biochemical pregnancy experience after assisted reproductive technology (ART) treatment.
Inclusion criteria:
  • At least 1 (maximum 3) miscarriage and/or biochemical pregnancy after ART treatment


Exclusion criteria:
  • Frozen spermatozoa

  • Frozen oocytes

  • Women with polycystic ovaries (PCO) and polycystic ovarian syndrome (PCOS)

  • Women with more than 4 ART treatments

Interventions Intervention: embryo culture in EmbryoGen medium
Control: embryo culture in ISM1 medium
Outcomes Primary outcome measure:
Ongoing pregnancy rate after 12 weeks of gestation [ Time Frame: 12 weeks after conception ]
Secondary outcome measure:
Ongoing implantation rate after 12 weeks of gestation [ Time Frame: 12 weeks after conception ]
Notes Country of recruitment: Italy
Unable to determine if women or oocytes were randomised