Sperm Selection Methods for Infertility

(EPIC Trial)

Overseen By Caroline Clinical Research Nurse, BSN, RN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Reproductive Medicine Associates of New Jersey

Disqualifiers: Azoospermia, Oligozoospermia, Donor sperm, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1-2 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different sperm selection techniques impact fertility treatments, specifically focusing on in vitro fertilization (IVF). Researchers compare two methods: one using a microfluidic device (Zymot) and the other using a common laboratory technique called density grade centrifugation. They aim to determine which method might improve the success rates of intracytoplasmic sperm injection (ICSI), a procedure where sperm is directly injected into an egg. Ideal participants are couples undergoing their first IVF cycle, planning a single embryo transfer, and have a male partner without sperm count issues. As an unphased trial, participants can contribute to pioneering research that could enhance fertility treatment success rates.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these sperm selection methods are safe for IVF?

Research has shown that the Zymot sperm selection device may improve fertility outcomes. Studies have found that using Zymot can lead to better-quality embryos and higher pregnancy rates. It also selects sperm with less DNA damage, benefiting assisted reproductive techniques.

In contrast, density gradient centrifugation (DGC) is a well-established method for preparing sperm. It significantly reduces DNA damage, which is crucial for successful fertilization. DGC is a common technique that has been used safely for a long time in fertility treatments.

Both methods are generally safe, with no major safety issues reported in studies. They aim to enhance the quality of sperm used in procedures like in vitro fertilization (IVF), potentially increasing pregnancy chances. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative sperm selection techniques for improving infertility treatments. The Zymot microfluidic device offers a new way to prepare sperm by using tiny channels to select the healthiest sperm, potentially increasing the success rate of procedures like ICSI (intracytoplasmic sperm injection). This method contrasts with the traditional density grade centrifugation, which separates sperm based on weight and density. By comparing these two approaches, the trial aims to determine if the microfluidic method can enhance fertilization outcomes, offering new hope to couples struggling with infertility.

What evidence suggests that these sperm selection methods are effective for infertility?

This trial will compare two sperm selection methods for infertility treatment: the Zymot sperm selection device and density gradient centrifugation (DGC). Research has shown that the Zymot device might increase pregnancy rates, especially when sperm DNA is damaged. Studies have found that using Zymot can lead to better quality embryos and a higher chance of pregnancy. One study noted a significant improvement in early pregnancy rates with the Zymot method.

Conversely, DGC is a common technique used to prepare sperm for fertility treatments. It effectively recovers more sperm, particularly from lower-quality samples, and is a well-established method that works well with reproductive technologies like IVF.

Both methods aim to select healthier sperm for fertilization, but the Zymot device shows promising improvements in certain situations compared to the traditional DGC method. Participants in this trial will have oocytes inseminated by sperm prepared using either the Zymot device or DGC, allowing for a direct comparison of these methods. ^{3 6 7 8 9}

Who Is on the Research Team?

Kassie Bollig, MD, MSCE

Principal Investigator

Reproductive Medicine Associates of New Jersey

Are You a Good Fit for This Trial?

This trial is for couples facing infertility where the male partner's age might affect sperm quality. Women must be between 18-42 years old, undergoing their first IVF cycle, and choosing single embryo transfer with genetic testing of embryos. Men should have a sufficient number of good-quality sperm after preparation.

Inclusion Criteria

I am starting my first IVF treatment cycle.

I am choosing to have one embryo transferred.

My egg count (AFC) is 8 or more.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo in vitro fertilization treatment using either Zymot or DGC sperm preparation for ICSI

1-2 weeks

Multiple visits for oocyte retrieval and ICSI procedure

Follow-up

Participants are monitored for fertilization, blastulation, and pregnancy outcomes

7 months

Regular follow-up visits up to 7 months post positive beta hCG

Long-term follow-up

Monitoring of live birth rates and ongoing pregnancy outcomes

7 months after discharge to obstetrician

What Are the Treatments Tested in This Trial?

Interventions

• Density grade centrifugation
• Zymot

Trial Overview The study compares two methods of preparing sperm for IVF: traditional density gradient centrifugation (DGC) and a newer microfluidic device called Zymot. It aims to see if the man's age affects success rates when using these different techniques.

How Is the Trial Designed?

Group I: Oocytes inseminated by sperm prepared via density grade centrifugation Experimental Treatment 1 Intervention

The other half of the mature oocytes will be allocated to receive sperm prepared by DGC. This sperm will be used by the embryologist for the ICSI procedure.

Group II: Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device Experimental Treatment 1 Intervention

Half of the mature oocytes will be randomly allocated to receive sperm prepared by the microfluidic (Zymot) sperm preparation device. This sperm will be used by the embryologist for the ICSI procedure.

Who Is Running the Clinical Trial?

Reproductive Medicine Associates of New Jersey

Lead Sponsor

Trials

56

Recruited

38,200+

Published Research Related to This Trial

In a study involving 25 normozoospermic patients, the ZSC-II sperm preparation technique resulted in a higher recovery of motile sperm compared to the Sperm Select method, indicating its potential effectiveness for assisted reproductive technologies.

The ZSC-II technique also demonstrated a better survival rate of sperm over 72 hours, which may enhance the chances of successful fertilization and pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of two devices for in vitro preparation of human sperm. Zavos, PM., Zarmakoupis-Zavos, PN., Correa, JR., et al.[2019]

The study compared the efficacy of the new Multi-ZSC system for separating human sperm against the traditional double-wash swim-up method.

Results indicated that the double-wash swim-up method selects sperm with superior head shape and better ability to undergo acrosome reaction, suggesting it may be more effective for certain fertility applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Multi-ZSC one-step standardized swim-up method to the double-wash swim-up method with regard to the effects of sperm separation on morphology, head morphometry, and acrosome reaction inducibility. Lampiao, F., du Plessis, SS.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9953211/

Analyzing the Differential Impact of Semen Preparation ... The current study aimed to assess the prognostic value of four sperm selection techniques: density gradient centrifugation (DGC), swim-up (SU), DGC-SU and DGC.

2. mefj.springeropen.com mefj.springeropen.com/articles/10.1186/s43043-022-00108-4

Efficacy of density gradient centrifugation technique (DGC) in ... Density gradient centrifugation (DGC) is commonly used for sperm preparation before assisted reproductive technology (ART) procedures.

3. nature.com nature.com/articles/s41598-020-59347-y

Sperm enrichment from poor semen samples by double ... Our results showed that double DGC (DDGC) is effective at increasing the sperm recovery rate from poor semen samples.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211525008218

Effect of sperm swim − up vs density gradient centrifugation ... The SU method yielded a higher proportion of Grade A embryos but did not reduce aneuploidy rates, suggesting its potential as a simpler, cost-effective ...

5. fertstert.org fertstert.org/article/S0015-0282(23)00524-1/fulltext

The impact of different sperm preparation methods on ... To assess the impact of 2 different sperm preparation methods, density gradient centrifugation and simple wash, on clinical pregnancy and live birth rates.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4250460/

Assessment of density gradient centrifugation (DGC) and ... Conclusions. DGC highly significantly reduces sperm DNA fragmentation in the semen of ICSI patients, with the exception of those with severe oligozoospermia.

7. fertstert.org fertstert.org/article/S0015-0282(21)01352-2/fulltext

IMPROVING IVF CLINICAL Results WITH ... The DSU method showed comparable outcome with the DG method for ICSI sperm preparation on fertilization rate and blastocyst formation rate.

8. imrpress.com imrpress.com/journal/CEOG/52/9/10.31083/CEOG43582/pdf

Double Density Gradient Centrifugation as a Routine ... The method is simple, requires no additional equipment, and may be considered as a routine sperm preparation technique for MESO in clinical use.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5473700/

Comparison of in vitro fertilization outcomes in ICSI cycles ... The most used techniques are density gradient (DG) centrifugation and swim-up (SU) in cases of normospermia or moderate oligoasthenoteratozoospermia.