InfertilityNCT05611164
Evaluation of SiD's System for Improving Assisted Reproduction Treatments
A study testing Software assisted selection of individual spermatozoa for intracytoplasmic sperm injection in people with Infertility, run by IVF 2.0 Limited at 2 sites in Mexico.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Software assisted selection of individual spermatozoa for intracytoplasmic sperm injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Apr 2022to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- Inability to reliably trace sperm-oocyte-embryo throughout the process.
- Oocytes that are not in Metaphase II.
- Patients with immotile sperm
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
New Hope Fertility Center
Guadalajara, Jalisco, 44630
New Hope Fertility Center
Mexico City, 11000
About this study
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.
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.
Read more
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.
- Conditions
- Infertility
- Being tested
- Software assisted selection of individual spermatozoa for intracytoplasmic sperm injection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Software assisted selection of individual spermatozoa for intracytoplasmic sperm injectionDevice
Half of the oocytes will be injected with a sperm selected with SiD's assistance
| Study group | Role | What they receive |
|---|---|---|
| Sperm selected by embryologist without software assistance | No intervention | 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. |
| Sperm selected with AI assistant SiD | Experimental | 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. Receives: Device: Software assisted selection of individual spermatozoa for intracytoplasmic sperm injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Rate of oocytes that present two pronuclei or cell division
Measured: 16-18 hours after ICSI
Blastocyst formation rate
Rate of oocytes that have a defined trophectoderm and inner cell mass
Measured: around 120 hours after ICSI
Usable blastocyst formation rate
Rate of oocytes that have a blastocyst that is transferable accoring to its quality
Measured: around 120 hours after ICSI
Secondary outcomes (3)
Ploidy status
euploid rate (when available)
Measured: trophectoderm biopsy is performed around 120 hours after ICSI
Biochemical pregnancy
human beta chorionic gonadotropin
Measured: 2 weeks after blastocyst transference
Clinical pregnancy
Presence of heartbeat
Measured: 6 weeks after blastocyst transference
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Apr 2022
- Primary completion5 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVF 2.0 Limited
- Sponsor type
- University, hospital or other
- Collaborators
- New Hope Fertility Center Mexico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611164
- Sponsor's protocol ID
- P002-SP002
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05611164
- Acronym / sponsor ID
- P002-SP002
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IVF 2.0 LimitedUniversity, hospital or other
- Collaborators
- New Hope Fertility Center Mexico
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sperm selected by embryologist without software assistance | No intervention | –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. |
| Sperm selected with AI assistant SiD | Experimental | Device: Software assisted selection of individual spermatozoa for intracytoplasmic sperm injectionFor 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Software assisted selection of individual spermatozoa for intracytoplasmic sperm injectionHalf of the oocytes will be injected with a sperm selected with SiD's assistance | Device | Sperm selected with AI assistant SiD |
Primary outcome
Fertilization rate
Time frame: 16-18 hours after ICSI
Rate of oocytes that present two pronuclei or cell division
Blastocyst formation rate
Time frame: around 120 hours after ICSI
Rate of oocytes that have a defined trophectoderm and inner cell mass
Usable blastocyst formation rate
Time frame: around 120 hours after ICSI
Rate of oocytes that have a blastocyst that is transferable accoring to its quality
3 secondary outcomes
Ploidy status
Time frame: trophectoderm biopsy is performed around 120 hours after ICSI
Biochemical pregnancy
Time frame: 2 weeks after blastocyst transference
Clinical pregnancy
Time frame: 6 weeks after blastocyst transference
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Software assisted selection of individual spermatozoa for intracytoplasmic sperm injection in people with Infertility, run by IVF 2.0 Limited at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate (time frame: 16-18 hours after ICSI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.