An interventional study of Software assisted selection of individual spermatozoa for intracytoplasmic sperm injection in Infertility, sponsored by IVF 2.0 Limited. Completed at 2 sites in Mexico. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by IVF 2.0 Limited · Not applicable, Interventional, and Treatment
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 60 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
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Exclusion Criteria:
For each patient, oocytes collected following one ovarian stimulation cycle are randomly distributed in two groups ("no intervention" and "experimental" arms), in a sibling oocyte study design. In the "no intervention" arm, the individual spermatozoa for injection are selected subjectively by the embryologist.
For each patient, oocytes collected following one ovarian stimulation cycle are randomly distributed in two groups ("no intervention" and "experimental" arms), in a sibling oocyte study design. In the "experimental" arm, the spermatozoa selection for injection is performed based on the recommendation of the AI assistant SiD.
Device: Software assisted selection of individual spermatozoa for intracytoplasmic sperm injection
Half of the oocytes will be injected with a sperm selected with SiD's assistance
Fertilization rate
Rate of oocytes that present two pronuclei or cell division
Time frame: 16-18 hours after ICSI
Blastocyst formation rate
Rate of oocytes that have a defined trophectoderm and inner cell mass
Time frame: around 120 hours after ICSI
Usable blastocyst formation rate
Rate of oocytes that have a blastocyst that is transferable accoring to its quality
Time frame: around 120 hours after ICSI
Ploidy status
euploid rate (when available)
Time frame: trophectoderm biopsy is performed around 120 hours after ICSI
Biochemical pregnancy
human beta chorionic gonadotropin
Time frame: 2 weeks after blastocyst transference
Clinical pregnancy
Presence of heartbeat
Time frame: 6 weeks after blastocyst transference
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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