Evaluation of SiD's System for Improving Assisted Reproduction Treatments
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      According to the WHO, infertility affects 15% of reproductive age couples worldwide. Among
      the assisted reproductive technologies available for patients with infertility,
      intracytoplasmic sperm injection (ICSI) has become one of the most widely employed and is now
      thought to be the most common method for oocyte insemination outside of the human body.

      ICSI entails the selection of an individual sperm cell and its injection directly into an
      oocyte. Usually, an embryologist performs the selection of the individual sperm cell to
      inject by subjectively observing the morphology and progression of the candidate
      spermatozoon. Subjectivity and time constrains, however, suggest the best possible candidate
      might not always be selected. Further optimization of ICSI technology remains a significant
      goal, yet the majority of approaches proposed in the literature have returned mixed results.
      The deployment of an artificial intelligence (AI) software capable of detecting and
      non-invasively predicting the value of individual spermatozoa in real time could
      significantly improve ICSI.

      SiD (IVF 2.0 Ltd, London, UK) is a software designed to identify, evaluate, and assist in the
      spermatozoon selection process ahead of ICSI. SID uses a mathematical model to evaluate
      individual spermatozoa in real-time according to their motility patterns (for instance
      velocity, linearity, straightness) and their morphology. The software has been developed by
      making use of retrospective data analysis, but its prospective evaluation is still pending.

      With the above in mind, this study intends to address the following question: can the use of
      a software assistant for the selection of individual sperm cells for injection (SiD), improve
      ICSI outcomes (oocyte fertilization, embryo development and quality, embryo ploidy,
      pregnancy, and live birth)? Patients with a clinical indication for undergoing ICSI will be
      prospectively enrolled into the study. Following ovarian stimulation, the oocytes retrieved
      from each patient will be randomly split into two groups and inseminated by ICSI using sperm
      selected either subjectively by an embryologist (control group) or by the software assistant
      SiD (experimental group). Embryos will be allowed to develop for up to six days and until
      blastocyst formation assessments are completed. Embryos might be subjected to cytogenetic
      screening or used for embryo transfer according to patient needs. The recorded outcomes will
      be anonymized prior to statistical analysis.
    


Intervention name(s): Software assisted selection of individual spermatozoa for intracytoplasmic sperm injection
Intervention type(s): Device
Intervention description(s): Half of the oocytes will be injected with a sperm selected with SiD's assistance
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment