Doctor-Selected vs Lab-Selected Sperm for IVF

Overseen By Christine V Whitehead, BSN, RN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: IVI America

Disqualifiers: Azoospermia, Oligozoospermia, Y-chromosome microdeletion, others

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

Compensation: Varies

Number of Visits: 25

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of selecting sperm for intracytoplasmic sperm injection (ICSI), a crucial step in in vitro fertilization (IVF). The first method, Routine Embryologist Selected Sperm, involves an embryologist selecting sperm based on appearance and movement. The second method, Zona Pellucida-Bound Sperm Selection for ICSI, uses sperm that naturally bind to a specific part of the egg. The trial aims to determine if one method is more effective in treating infertility. Participants qualify if they are undergoing their first IVF cycle and plan to transfer a single embryo after genetic testing. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research in infertility treatment.

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

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

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

Research has shown that using sperm attached to the zona pellucida (ZP), a protective layer around the egg, for intracytoplasmic sperm injection (ICSI) is generally safe. Studies suggest this method might improve embryo quality and quantity, potentially leading to better pregnancy outcomes. Importantly, no major safety concerns have emerged with this sperm selection technique.

In comparison, the usual method involves an embryologist selecting the sperm, which remains the current standard practice and is known to be safe. Both methods aim to find the best sperm for fertilization, and research has not identified any significant safety issues with either approach. Participants can feel confident about the safety of both treatments under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to selecting sperm for in vitro fertilization (IVF). Unlike the standard method where embryologists choose sperm based on their appearance and movement, this new technique uses sperm that naturally bind to the zona pellucida (ZP) of an immature egg. This ZP-bound selection could potentially lead to better fertilization outcomes by mimicking a more natural selection process. By comparing these methods, researchers hope to find out if ZP-bound sperm selection can improve success rates for couples undergoing IVF.

What evidence suggests that this trial's treatments could be effective for infertility?

This trial will compare two methods for selecting sperm for intracytoplasmic sperm injection (ICSI): Routine Embryologist Selected Sperm and Zona Pellucida-Bound Sperm Selection. Research has shown that using sperm attached to the zona pellucida (ZP), a protective layer around the egg, for ICSI might improve the quality and number of usable embryos. Some studies suggest it could lead to better pregnancy outcomes, although it doesn't seem to affect early embryo development. However, other research found no significant difference between using ZP-bound sperm and the traditional method regarding fertilization and pregnancy rates. A meta-analysis, which combines results from multiple studies, indicated that ZP-bound sperm might slightly increase the chances of implantation and clinical pregnancy. Overall, the evidence is mixed, showing some promising signs but no clear advantage over current methods. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Couples facing infertility, where the female is under 42 but over 18 years old with normal ovarian reserve and undergoing their first IVF cycle. They must elect single embryo transfer and preimplantation genetic testing for aneuploidy. Exclusions include males with certain genetic abnormalities or those needing surgically obtained sperm.

Inclusion Criteria

My fertility tests show normal ovarian function.

Undergoing their first in vitro fertilization (IVF) cycle

Electing single embryo transfer

Exclusion Criteria

I cannot undergo IVF due to health reasons.

My male partner does not have a normal XY chromosome pattern.

My uterus lining is too thin or I have persistent fluid in my uterus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ICSI with either ZP-bound sperm or embryologist selected sperm

1 week

1 visit (in-person) for oocyte retrieval and ICSI procedure

Follow-up

Participants are monitored for blastulation, fertilization, and ploidy rates

2 weeks

Follow-up assessments at 24 hours and 2 weeks post-ICSI

Sustained Implantation Monitoring

Participants are monitored for sustained implantation rates and discharged at 8-9 weeks gestational age

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Routine Embryologist Selected Sperm
• Zona Pellucida-Bound Sperm Selection for ICSI

Trial Overview

The trial compares two methods of selecting sperm for ICSI during IVF: one using zona pellucida-bound sperm and the other using routine embryologist selection to see which method improves pregnancy outcomes.

How Is the Trial Designed?

Group I: ZP Bound Sperm Selection Oocyte Cohort Experimental Treatment 1 Intervention

This is half of the patient's mature oocytes that will be inseminated via the ICSI procedure with sperm that has bound to the ZP of an immature oocyte.

Group II: Routine Care: Embryologist Selected Sperm Oocyte Cohort Experimental Treatment 1 Intervention

This is half of the patient's mature oocytes that will be inseminated via the ICSI procedure per routine with sperm that is subjectively selected by the embryologist (based on morphology and mobility characteristics). This is the current standard of care for ICSI.

Routine Embryologist Selected Sperm is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as ICSI with Embryologist Selection for:

• Male infertility
• Unexplained infertility
• Preimplantation genetic testing (PGT)
• Low oocyte yield
• Prior failed fertilization with conventional insemination

Approved in United States as ICSI with Embryologist Selection for:

• Male infertility
• Unexplained infertility
• Preimplantation genetic testing (PGT)
• Low oocyte yield
• Prior failed fertilization with conventional insemination

Approved in Canada as ICSI with Embryologist Selection for:

• Male infertility
• Unexplained infertility
• Preimplantation genetic testing (PGT)
• Low oocyte yield
• Prior failed fertilization with conventional insemination

Who Is Running the Clinical Trial?

IVI America

Lead Sponsor

Trials

1

Recruited

200+

Published Research Related to This Trial

The study compared two methods of sperm selection for intracytoplasmic sperm injection (ICSI): ZP-ICSI, which uses sperm that binds to the zona pellucida, and conventional ICSI, but found no significant differences in fertilization or pregnancy rates between the two methods.

However, higher sperm concentration and morphology were linked to better ZP-sperm binding, suggesting that while ZP-ICSI isn't superior, effective binding may indicate better sperm quality and potentially improve pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional intracytoplasmic sperm injection provides equivalent outcomes compared with human zona pellucida-bound selected sperm injection. Casciani, V., Minasi, MG., Fabozzi, G., et al.[2022]

Using zona pellucida (ZP)-bound sperm for intracytoplasmic sperm injection (ICSI) resulted in a higher percentage of high-quality embryos and usable embryos compared to standard ICSI methods, with significant differences in embryo quality (66.1% vs. 50.8%).

Although the clinical pregnancy rate was higher in the ZP-bound sperm group (60.5%) compared to the control group (47.6%), this difference was not statistically significant, suggesting potential benefits in embryo quality that may lead to improved pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of intracytoplasmic sperm injection using the zona pellucida-bound sperm or manually selected sperm. Jin, R., Bao, J., Tang, D., et al.[2022]

In a study comparing conventional ICSI with modified ICSI using zona pellucida (ZP)-bound sperm, no significant differences were found in fertilization, embryo development, or overall pregnancy rates among 39 couples in each group.

However, the modified ICSI with ZP-bound sperm showed higher implantation and clinical pregnancy rates, suggesting potential benefits that warrant further investigation with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of outcomes of conventional intracytoplasmic sperm injection and intracytoplasmic sperm injection using sperm bound to the zona pellucida of immature oocytes. Black, M., Liu, DY., Bourne, H., et al.[2022]

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 reviewed 50 articles and included 5 studies, finding that selecting zona pellucida (ZP)-bound sperm does not significantly improve overall ICSI outcomes, although there is a slight improvement in implantation rates.

When one study was excluded from the analysis, ZP-bound sperm selection showed improved embryo quality, implantation rates, and clinical pregnancy rates, suggesting potential benefits that need further investigation with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of zona pellucida-bound spermatozoa as a natural selection in improvement of ICSI outcomes: A systematic review and meta-analysis. Izadi, M., Khalili, MA., Salehi-Abargouei, A., et al.[2021]

The modified ICSI technique using zona pellucida-bound sperm resulted in a higher proportion of high-quality embryos and a better implantation rate compared to conventional ICSI, based on a study of 106 couples (53 in each group).

Although the test group achieved more pregnancies (26) than the control group (19), the difference in fetal heart pregnancy rates was not statistically significant, indicating that while the modified technique shows promise, it does not guarantee improved pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of zona pellucida-bound sperm for intracytoplasmic sperm injection produces higher embryo quality and implantation than conventional intracytoplasmic sperm injection. Liu, F., Qiu, Y., Zou, Y., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4870439/

Outcomes of intracytoplasmic sperm injection using the ...

ICSI using ZP-bound sperm might increase the embryo quality and number of useable embryos, possibly improving the clinical pregnancy outcome of ICSI.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05724979

Outcome of Using Sperm Bound to the Zona Pellucida ...

Our results showed no statistically significant superiority for the ZP binding technique over the conventional sperm selection with respect to the rates of ...

3.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/15579883241228236

Sperm Selection Using Zona Pellucida–Binding Enhanced ...

Sperm selection using biological materials, such as ZP, improved both embryo quality and pregnancy outcomes, despite not affecting the early embryo development.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0015028209036176

Comparison of outcomes of conventional intracytoplasmic ...

Overall, there were no statistically significant differences in fertilization, embryo quality, implantation, and clinical pregnancy rates between ICSI patients ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/and.14022

Use of zona pellucida‐bound spermatozoa as a natural ...

In conclusion, the results of meta-analysis revealed that ZP-bound spermatozoa can partially improve implantation and clinical pregnancy rates.

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1472648309000844

Outcome of ICSI using zona pellucida-bound spermatozoa ...

These findings suggest that the spermatozoa–zona pellucida binding test may be an efficient method to identify the most competent spermatozoa for ICSI.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05859152

Zona Pellucida Bound Sperm vs. Embryologist Selected ...

This study aims to assess the clinical significance of the intracytoplasmic sperm injection (ICSI) with zona-pellucida (ZP) bound sperm compared to ICSI with ...

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academic.oup.com

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Improving sperm selection strategies for assisted reproduction ...

We have given consideration to the events associated with sperm maturation and the importance of zona pellucida (ZP) binding as inspiration to inform the ...