Evaluation of SiD's System for Improving Assisted Reproduction Treatments

SiD, an Assistant for Sperm Selection During Intracytoplasmic Sperm Injection in Medically Assisted Reproduction: Effect on Fertilization, Blastocyst Formation, Early Pregnancy Loss, and Consistent Practice. A Prospective Pilot Study.

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Device: Software assisted selection of individual spermatozoa for intracytoplasmic sperm injection

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 11000
    • New Hope Fertility Center
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44630
      • New Hope Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Participant's age between 18 and 40 years of age.
• Informed consent signed by the patient before treatment.
• IVF treatments with medical or embryology indication to perform ICSI.
• Cycles with at least 2 oocytes in Metaphase II.
• Fresh ejaculated motile sperm.
• Fresh oocytes.
• Selection of sperm using a 7% or 10% PVP solution.
• Presence of motile sperm at the time of sperm selection for ICSI.
• Videos recorded with a total magnification of 200x.

Exclusion Criteria:

• Patients diagnosed with recurrent pregnancy loss.
• Spermatozoa extracted by testicular biopsy.
• Frozen/thawed spermatozoa.
• Frozen/thawed oocytes in any case.
• That the recommendations for use of SiD have not been fully followed.
• Poor quality of saved ICSI video.
• Inability to reliably trace sperm-oocyte-embryo throughout the process.
• Oocytes that are not in Metaphase II.
• Patients with immotile sperm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Sperm selected by embryologist without software assistance; 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.
Experimental: Sperm selected with AI assistant SiD; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization rate	Rate of oocytes that present two pronuclei or cell division	16-18 hours after ICSI
Blastocyst formation rate	Rate of oocytes that have a defined trophectoderm and inner cell mass	around 120 hours after ICSI
Usable blastocyst formation rate	Rate of oocytes that have a blastocyst that is transferable accoring to its quality	around 120 hours after ICSI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ploidy status	euploid rate (when available)	trophectoderm biopsy is performed around 120 hours after ICSI
Biochemical pregnancy	human beta chorionic gonadotropin	2 weeks after blastocyst transference
Clinical pregnancy	Presence of heartbeat	6 weeks after blastocyst transference

Collaborators and Investigators

• Sponsor: IVF 2.0 Limited
• Collaborators: New Hope Fertility Center Mexico

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): September 5, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: P002-SP002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No