InfertilityNCT05859152
Zona Pellucida Bound Sperm vs. Embryologist Selected Sperm for Intracytoplasmic Sperm Injection
A study testing Zona Pellucida-Bound Sperm Selection for ICSI and Routine Embryologist Selected Sperm in people with Infertility, run by IVI America at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 41 years
- Conditions the study is for
- Infertility
- What is being tested?
- Zona Pellucida-Bound Sperm Selection for ICSI and Routine Embryologist Selected Sperm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2023to 14 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 41 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing their first in vitro fertilization (IVF) cycle
- Electing single embryo transfer
- Electing preimplantation genetic testing for aneuploidy (PGT-A) of their embryos
- Female partners age <42 years old at start of vaginal oocyte retrieval cycle, but >18 years old.
- Normal ovarian reserve:
- Antimullerian hormone level (AMH) ≥ 1.2 ng/mL
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- Antral follicle count (AFC) ≥ 8
- At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize
- At least 1 immature oocyteretrieved at the VOR procedure to perform ZP binding co-incubation procedure
- Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure
Who cannot join
- Contraindication to IVF
- Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis)
- Male partner with azoospermia or oligozoospermia (<100,000 total motile spermatozoa)
- Male partner with Y-chromosome microdeletion
- Male partner with any Karyotype other than 46,XY
- Male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures
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- Uncorrected hydrosalpinges that communicate with the endometrial cavity
- Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness <6mm,), or persistent endometrial fluid
- Donor oocyte cycles
- Gestational carriers
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Associates of Northern California
San Francisco, California, 94105
About this study
Official title: Comparing the Outcomes of Intracytoplasmic Sperm Injection (ICSI) Using the Zona Pellucida-Bound Sperm Versus Conventional Manually Selected Sperm
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.
Read the detailed description
In this study, the investigators aim to determine the clinical utility of the ZP-bound sperm selection methodology for ICSI. This study will be a prospective, split cohort, randomized, control trial comparing the routine standard of sperm selection for ICSI via the embryologist versus sperm selected via ZP-binding for ICSI. Embryology, ploidy and clinical pregnancy outcomes will be assessed.
- Conditions
- Infertility
- Being tested
- Zona Pellucida-Bound Sperm Selection for ICSI, Routine Embryologist Selected Sperm
- Keywords
- Intracytoplasmic Sperm Injection Procedure, ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zona Pellucida-Bound Sperm Selection for ICSIOther
one half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that was bound to the ZP of an immature oocyte.
Routine Embryologist Selected SpermOther
one half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that has been selected based on morphology and mobility characteristics by the embryologist per routine.
| Study group | Role | What they receive |
|---|---|---|
| ZP Bound Sperm Selection Oocyte Cohort | Experimental | 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. Receives: Other: Zona Pellucida-Bound Sperm Selection for ICSI |
| Routine Care: Embryologist Selected Sperm Oocyte Cohort | Other | 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. Receives: Other: Routine Embryologist Selected Sperm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastulation Rate
Blastulation rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI.
Measured: one week after the vaginal oocyte retrieval and ICSI procedure
Secondary outcomes (3)
Fertilization Rate
fertilization rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI.
Measured: 24 hours post ICSI procedure
Blastocyst Ploidy Rate
Preimplantation genetic testing for aneuploidy will be performed at the blastocyst stage and ploidy status compared between groups
Measured: Approximately 2 weeks after trophectoderm biopsy
Sustained Implantation Rates
The number of participants discharged at 8-9 weeks gestational age to their obstetrician.
Measured: Approximately 6 weeks after frozen embryo transfer procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start3 Nov 2023
- Primary completion2 Dec 2024
- Study completion14 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI America
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859152
- Sponsor's protocol ID
- IVIRMA-NorCal-Z01
- Status last verified
- Jan 2026
- First submitted
- 4 May 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Outcomes of Intracytoplasmic Sperm Injection (ICSI) Using the Zona Pellucida-Bound Sperm Versus Conventional Manually Selected Sperm
- ClinicalTrials.gov ID
- NCT05859152
- Acronym / sponsor ID
- IVIRMA-NorCal-Z01
- Conditions
- Infertility
- Keywords
- Intracytoplasmic Sperm Injection Procedure, ICSI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- IVI AmericaUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 14 Sep 2025 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, the investigators aim to determine the clinical utility of the ZP-bound sperm selection methodology for ICSI. This study will be a prospective, split cohort, randomized, control trial comparing the routine standard of sperm selection for ICSI via the embryologist versus sperm selected via ZP-binding for ICSI. Embryology, ploidy and clinical pregnancy outcomes will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZP Bound Sperm Selection Oocyte Cohort | Experimental | Other: Zona Pellucida-Bound Sperm Selection for ICSIThis 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. |
| Routine Care: Embryologist Selected Sperm Oocyte Cohort | Other | Other: Routine Embryologist Selected SpermThis 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. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Undergoing their first in vitro fertilization (IVF) cycle
- Electing single embryo transfer
- Electing preimplantation genetic testing for aneuploidy (PGT-A) of their embryos
- Female partners age <42 years old at start of vaginal oocyte retrieval cycle, but >18 years old.
- Normal ovarian reserve:
Key exclusion criteria (10 listed)
- Contraindication to IVF
- Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis)
- Male partner with azoospermia or oligozoospermia (<100,000 total motile spermatozoa)
- Male partner with Y-chromosome microdeletion
- Male partner with any Karyotype other than 46,XY
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zona Pellucida-Bound Sperm Selection for ICSIone half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that was bound to the ZP of an immature oocyte. | Other | ZP Bound Sperm Selection Oocyte Cohort |
| Routine Embryologist Selected Spermone half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that has been selected based on morphology and mobility characteristics by the embryologist per routine. | Other | Routine Care: Embryologist Selected Sperm Oocyte Cohort |
Primary outcome
Blastulation Rate
Time frame: one week after the vaginal oocyte retrieval and ICSI procedure
Blastulation rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI.
3 secondary outcomes
Fertilization Rate
Time frame: 24 hours post ICSI procedure
Blastocyst Ploidy Rate
Time frame: Approximately 2 weeks after trophectoderm biopsy
Sustained Implantation Rates
Time frame: Approximately 6 weeks after frozen embryo transfer procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zona Pellucida-Bound Sperm Selection for ICSI and Routine Embryologist Selected Sperm in people with Infertility, run by IVI America at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastulation Rate (time frame: one week after the vaginal oocyte retrieval and ICSI procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.