Evaluation of SiD's System for Improving Assisted Reproduction Treatments

Infertility Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05611164
• Other study ID #: P002-SP002
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: IVF 2.0 Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
Mexico	New Hope Fertility Center	Guadalajara	Jalisco
Mexico	New Hope Fertility Center	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
IVF 2.0 Limited	New Hope Fertility Center Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertilization rate	Rate of oocytes that present two pronuclei or cell division	16-18 hours after ICSI
Primary	Blastocyst formation rate	Rate of oocytes that have a defined trophectoderm and inner cell mass	around 120 hours after ICSI
Primary	Usable blastocyst formation rate	Rate of oocytes that have a blastocyst that is transferable accoring to its quality	around 120 hours after ICSI
Secondary	Ploidy status	euploid rate (when available)	trophectoderm biopsy is performed around 120 hours after ICSI
Secondary	Biochemical pregnancy	human beta chorionic gonadotropin	2 weeks after blastocyst transference
Secondary	Clinical pregnancy	Presence of heartbeat	6 weeks after blastocyst transference