What side effects are associated with this type of intervention?

Common infertility treatments, particularly those involving intracytoplasmic sperm injection (ICSI), can have side effects such as ovarian hyperstimulation syndrome (OHSS), multiple pregnancies, and potential risks to offspring like low birth weight and preterm birth. Using sperm with high DNA fragmentation in ICSI can result in lower fertilization rates, poor embryo development, and higher miscarriage rates. Automated sperm selection systems aim to reduce these risks by selecting sperm with low DNA fragmentation, improving outcomes and reducing subjectivity in sperm selection.

What prior FDA approvals exist?

The FDA has approved several treatments for infertility, including medications like clomiphene citrate (Clomid) and gonadotropins, which stimulate ovulation. Assisted reproductive technologies (ART) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) are also widely used. While specific FDA approvals for robotic sperm selection systems are not mentioned, techniques like density-gradient centrifugation and microfluidic sorting, which aim to select sperm with low DNA fragmentation, are being studied and utilized to improve ART outcomes.

What other types of research exist?

Promising novel alternatives to the Robotic Sperm Selection System for infertility patients include: 1) Microfluidic sorting, which selects sperm with reduced DNA damage compared to traditional methods. 2) Magnetic Activated Cell Sorting (MACS), which isolates viable non-apoptotic spermatozoa with intact membranes and high DNA integrity. 3) Fluorescence-Activated Cell Sorting (FACS), which uses staining strategies to sort sperm with low DNA fragmentation. These methods offer advanced, precise selection of sperm, potentially improving ART outcomes.

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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

Must not have

Cases where surgically-retrieved sperm is used for ICSI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 or 6 days

Awards & highlights

No Placebo-Only Group

Summary

This trial involves a new robotic system designed to help select the best sperm for fertilization. It targets patients who have high levels of sperm DNA damage and face repeated IVF failures. The system uses a camera and software to analyze sperm quality and choose those with the least DNA damage, aiming to improve fertilization rates and reduce miscarriages.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My partner's sperm was surgically retrieved for our fertility treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 or 6 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blastocyst formation rate

Embryo morphology grade as evaluated by the SART grading system

Fertilization rate

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The robotic sperm selection system improves infertility treatment by using automated image analysis and software to select sperm with low DNA fragmentation, thereby enhancing the quality of sperm used in intracytoplasmic sperm injection (ICSI). This reduces subjectivity and inconsistency in manual selection, leading to better embryo development, higher implantation rates, and lower miscarriage rates. This is crucial for infertility patients as it increases the likelihood of successful fertilization and healthy pregnancy outcomes. Other common treatments include hormonal therapies to stimulate spermatogenesis and assisted reproductive technologies like IVF and ICSI, which address sperm quality and quantity issues.

Clinical application of aromatase inhibitors to treat male infertility.Quantitative selection of single human sperm with high DNA integrity for intracytoplasmic sperm injection.Knowledge gaps in male infertility: a reproductive endocrinology and infertility perspective.