Use of the SiDTM v2.0 Algorithm to Assist Embiyologists in Sperm Selection During ICSI Procedures (SID_3)

September 2, 2025 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA

Use of the SiDTM v2.0 Algorithm to Assist Embryologists in Sperm Selection During ICSI Procedures: Impact in Biological and Clinical Outcomes

Infertility is defined as a failure of a couple to achieve a pregnancy after 12 or more months of unprotected intercourse. Males are found to be solely responsible for 20-30% of infertility cases but contribute to 50% of cases overall. The selection of sperm to microinject is completely subjective and there is high intra- and inter- observer variability. SiDTM v2.0 is an algorithm which analyses real-time seminal samples located at ICSI dishes. Particularly, it assesses morphology and several motility parameters of each sperm, and it assigns a categorical and numerical score to each one. Categorical scores are represented by colours: green colour for optimal sperm, yellow for good sperm, orange for medium-quality sperm and red for low-quality sperm. Numerical scores ranged from 0 to 100, with higher scores for those best-quality sperm. SiDTM v2.0 can reduce subjectivity of the sperm selection process to the maximum, selecting the optimal sperm in real time. In addition, it could help junior embryologists to perform this complex and tedious procedure, which is the sperm selection for ICSI. To carry out the study, we will conduct a prospective cohort study in a total of 100 couples. Therefore, the aim of this study is to validate SiDTM v2.0 as an useful Artificial Intelligence-tool for sperm selection; that means achieving , at least, same clinical results as sperm selection performed by the embryologist.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with indication for ICSI.
  • Women of advanced maternal age (>35 years) in whom at least 4 oocytes in metaphase II stages are obtained in the follicular puncture, without excluding patients from the oocyte donation program.
  • Sperm obtained by masturbation with a concentration above 1 million spermatozoa/mL after sperm capacitation.
  • Normal karyotype of both partners.
  • Informed Consent (IC).

Exclusion Criteria:

  • Patients diagnosed with recurrent gestational loss.
  • Semen extracted by testicular biopsy.
  • Semen samples with globozoospermia (sperm defect due to lack of acrosome) or azoospermia (absence of spermatozoa in the ejaculate).
  • Semen samples treated with pentoxifylline.
  • ICSI cycles with application of calcium ionophore. o ICSI cycles with application of calcium ionophore.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SID
Half of the MII oocytes obtained will be microinjected with spermatozoa selected by SiD TM
Diagnostic test: Automated Sperm Selection
This group of oocytes will be microinjected with sperm selected by the second version of SID TM (SID V2.0) wich analyses additional sperm parameters than first version of SID TM (SID V1.0).
Active Comparator: NO-SID
Half of the MII oocytes obtained will be microinjected with spermatozoa selected by embriologist.
Diagnostic test: Conventional Sperm Selection
Half of the oocytes will be microinjected with sperm selected by the embryologist without SID assistance, based on the conventional and visual assesment of seminal samples located at ICSI dishes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SID TM V2.0 VALIDATION
Time Frame: 1 year
The main objective of this study is to test whether assisted sperm selection using the artificial intelligence algorithm SiDTM v2.0 equals or exceeds the mean rate of useful blastocysts obtained by conventional unassisted sperm selection by SiDTM v2.0.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization assesment (SID vs NO SID)
Time Frame: 1 year
Fertilization rate (SID VS NO SID)
1 year
Embryo development assesment (SID vs NO SID)
Time Frame: 1 year
Embryo development rate (SID VS NO SID)
1 year
Clinical outcomes assesment (SID vs NO SID)
Time Frame: 1 year
Gestation rate.
1 year
Clinical outcomes assesment (SID vs NO SID)
Time Frame: 1 year
Implantation rate
1 year
Clinical outcomes assesment (SID vs NO SID)
Time Frame: 1 year
Live birth rate.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Collaborators

IVF 2.0 Limited

Investigators

  • Principal Investigator: Marcos Meseguer, PhD, IVIRMA Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

July 17, 2025

First Submitted That Met QC Criteria

September 2, 2025

First Posted (Estimated)

September 9, 2025

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2502-VLC-027-MM

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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