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

Trial Summary

What is the purpose of this trial?

This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in vitro fertilization treatment (IVF) of their infertility.

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 data supports the effectiveness of the treatment Density grade centrifugation, Zymot for infertility?

Research suggests that using density gradient centrifugation, a method to select healthier sperm, can improve sperm quality, which is linked to better pregnancy rates in assisted reproductive technologies. This method has shown positive results in improving sperm parameters, which are important for successful fertilization. ^{1 2 3 4 5}

Is sperm selection using methods like density gradient centrifugation and microfluidics safe for humans?

Sperm selection methods like density gradient centrifugation can generate reactive oxygen species (ROS) that may damage sperm DNA, but newer techniques like microfluidics avoid these steps and may improve sperm quality. There is no direct mention of safety concerns for humans, but these methods are commonly used in assisted reproductive technologies. ^{3 6 7 8 9}

How does the Zymot treatment for infertility differ from other treatments?

Zymot is unique because it uses microfluidic sorting to select sperm with lower DNA damage, which may be more effective than traditional methods like density gradient centrifugation. This approach focuses on improving sperm quality by reducing DNA fragmentation, potentially leading to better outcomes in assisted reproductive technologies. ^{10 11 12 13 14}

Research Team

Kassie Bollig, MD, MSCE

Principal Investigator

Reproductive Medicine Associates of New Jersey

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A comprehensive evaluation of pre- and post-processing sperm parameters for predicting successful pregnancy rate following intrauterine insemination with the husband's sperms. [2022]

2. Singapore pubmed.ncbi.nlm.nih.gov

Manual versus computer-automated semen analysis. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Does the use of microfluidic sperm sorting for the sperm selection improve in vitro fertilization success rates in male factor infertility? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Analysis of selected sperm by density gradient centrifugation might aid in the estimation of in vivo fertility of thawed ram spermatozoa. [2010]

6. England pubmed.ncbi.nlm.nih.gov

Sperm processing for advanced reproductive technologies: Where are we today? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of sperm separation methods before intrauterine insemination on pregnancy outcomes and live birth rates: Differences between the swim-up and microfluidic chip techniques. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The impact of different sperm preparation methods on clinical pregnancy and live birth rates in intrauterine insemination cycles: a retrospective single-center cohort study. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Semen processing by density gradient centrifugation is useful in selecting sperm with higher double-strand DNA integrity. [2011]

10. England pubmed.ncbi.nlm.nih.gov

Microfluidic sorting selects sperm for clinical use with reduced DNA damage compared to density gradient centrifugation with swim-up in split semen samples. [2020]

11. Australia pubmed.ncbi.nlm.nih.gov

A technique for enrichment of motile spermatozoa from oligozoospermic and asthenozoospermic patients. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Assessment of two devices for in vitro preparation of human sperm. [2019]

13. United States 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. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Nycodenz and Percoll density gradients for the selection of motile human spermatozoa. [2019]