200 Participants Needed

Doctor-Selected vs Lab-Selected Sperm for IVF

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Overseen ByChristine V Whitehead, BSN, RN
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: IVI America
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.12346

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.12346

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
See 1 more

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.
See 7 more

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?
2Treatment groups
Experimental Treatment
Group I: ZP Bound Sperm Selection Oocyte CohortExperimental Treatment1 Intervention
Group II: Routine Care: Embryologist Selected Sperm Oocyte CohortExperimental Treatment1 Intervention

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

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Approved in European Union as ICSI with Embryologist Selection for:
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Approved in United States as ICSI with Embryologist Selection for:
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Approved in Canada as ICSI with Embryologist Selection for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

IVI America

Lead Sponsor

Trials
1
Recruited
200+

Published Research Related to This Trial

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.
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.
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.
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

Comparison of outcomes of conventional intracytoplasmic sperm injection and intracytoplasmic sperm injection using sperm bound to the zona pellucida of immature oocytes. [2022]
Use of zona pellucida-bound spermatozoa as a natural selection in improvement of ICSI outcomes: A systematic review and meta-analysis. [2021]
Use of zona pellucida-bound sperm for intracytoplasmic sperm injection produces higher embryo quality and implantation than conventional intracytoplasmic sperm injection. [2022]
Outcomes of intracytoplasmic sperm injection using the zona pellucida-bound sperm or manually selected sperm. [2022]
Traditional intracytoplasmic sperm injection provides equivalent outcomes compared with human zona pellucida-bound selected sperm injection. [2022]
Assessment of two devices for in vitro preparation of human sperm. [2019]
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