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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to assess the clinical significance of the intracytoplasmic sperm injection (ICSI) with zona-pellucida (ZP) bound sperm compared to ICSI with embryologist selected sperm for patients undergoing in vitro fertilization treatment of their infertility.

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 data supports the effectiveness of the treatment Routine Embryologist Selected Sperm, Embryologist Selected Sperm for ICSI, Routine ICSI with Embryologist Selection, Zona Pellucida-Bound Sperm Selection for ICSI, Zona Pellucida-Bound Sperm Selection, ZP-Bound Sperm Selection, Sperm-Zona Pellucida Interaction?

Research suggests that using zona pellucida-bound sperm for intracytoplasmic sperm injection (ICSI) can improve embryo quality and implantation rates compared to conventional methods. However, the overall clinical pregnancy rates did not show significant differences, indicating that more studies are needed to confirm these findings. ^{1 2 3 4 5}

Is using doctor-selected or lab-selected sperm for IVF safe?

The studies reviewed do not report any specific safety concerns related to using zona pellucida-bound sperm for intracytoplasmic sperm injection (ICSI), suggesting it is generally safe. However, more research with larger groups is needed to confirm these findings. ^{1 2 3 4 6}

How does the treatment of zona pellucida-bound sperm selection for ICSI differ from other treatments for IVF?

This treatment is unique because it uses sperm that naturally bind to the zona pellucida (a protective layer around the egg) for selection, which may enhance embryo quality and implantation rates compared to conventional methods where scientists manually select sperm. ^{1 2 3 4 5}

Eligibility Criteria

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 female partner is between 18 and 42 years old.

My fertility tests show normal ovarian function.

Undergoing their first in vitro fertilization (IVF) cycle

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. Germany 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. [2021]

3. United States 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. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes of intracytoplasmic sperm injection using the zona pellucida-bound sperm or manually selected sperm. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Traditional intracytoplasmic sperm injection provides equivalent outcomes compared with human zona pellucida-bound selected sperm injection. [2022]

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

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