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Automated Sperm Selection for Infertility

N/A
Recruiting
Led By Yu Sun, PhD
Research Sponsored by Create Fertility Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing ICSI
Female partner between 19-43 years of age using own or donor oocytes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 or 6 days
Awards & highlights

Study Summary

This trial is testing a new robotic system that automates the selection of sperm for ICSI, in order to improve outcomes for patients by choosing sperm with low DNA fragmentation.

Who is the study for?
This trial is for couples facing infertility where the female partner is between 19-43 years old using her own or donor eggs. It's specifically for those undergoing ICSI, a type of IVF treatment. Men with completely immotile sperm, low normal-form morphology, or surgically-retrieved sperm are excluded.Check my eligibility
What is being tested?
The trial tests an automated system that selects sperm based on DNA quality to improve fertilization rates in ICSI procedures. This robotic system uses imaging and software analysis to reduce subjectivity compared to traditional manual selection by embryologists.See study design
What are the potential side effects?
Since this intervention involves selecting sperm rather than administering drugs or medical treatments, there are no direct side effects like you'd expect with medication. However, effectiveness and potential impacts on pregnancy rates will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am undergoing ICSI treatment.
Select...
My female partner is between 19-43 years old and using her own or donor eggs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 or 6 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 or 6 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blastocyst formation rate
Embryo morphology grade as evaluated by the SART grading system
Fertilization rate
Secondary outcome measures
Differences in early embryo cleavage divisions and late developmental (blastocyst) morphokinetics.
Differences in the proportion of euploid and aneuploid embryos between the two groups
Evaluation of patient demographic and stimulation cycle characteristics for confounding variables.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Automated sperm selectionExperimental Treatment1 Intervention
The only intervention is the additional sperm selection step using software immediately prior to ICSI.
Group II: Standard sperm selectionActive Control1 Intervention
In the control group the oocytes will be injected with sperm that is selected by embryologists using conventional methods in the IVF lab.

Find a Location

Who is running the clinical trial?

Create Fertility CenterLead Sponsor
2 Previous Clinical Trials
826 Total Patients Enrolled
University of TorontoOTHER
687 Previous Clinical Trials
1,018,040 Total Patients Enrolled
2 Trials studying Infertility
120 Patients Enrolled for Infertility
Yu Sun, PhDPrincipal InvestigatorUniversity of Toronto

Media Library

Automated Sperm Selection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05240469 — N/A
Infertility Research Study Groups: Standard sperm selection, Automated sperm selection
Infertility Clinical Trial 2023: Automated Sperm Selection Highlights & Side Effects. Trial Name: NCT05240469 — N/A
Automated Sperm Selection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05240469 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors eligible to partake in this clinical experiment?

"This study is recruiting individuals aged between 19 and 43 years."

Answered by AI

Are there any remaining opportunities to join this experiment?

"Data on clinicaltrials.gov suggests that this experiment is recruiting participants and was initially advertised on January 20th 2021 before being updated most recently on May 5th 2022."

Answered by AI

Do I fit the criteria to participate in this research project?

"Aspiring participants of this medical trial must demonstrate fertility issues and should be between 19 to 43 years old. The study is seeking to recruit 330 individuals in total."

Answered by AI

How many participants have signed up for the trial thus far?

"Affirmative, the information on clinicaltrials.gov indicates that this medical trial is actively recruiting participants. The study was initially announced on January 20th 2021 and updated lastly on May 5th 2022. At present, there are 330 patients sought across one location for enrolment in the experiment."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
North Carolina
What site did they apply to?
CReATe Fertility Centre
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
~45 spots leftby Sep 2024