InfertilityNCT01944332
Gamete Treatment to Correct Fertilization Failure
A study testing gamete treatment in people with Infertility, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
In this proposed research study, the investigators plan to assess the efficacy of gametes' (egg and sperm) treatment on fertilization as well as pre- and post-implantation embryo development. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Infertility
- What is being tested?
- gamete treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with complete fertilization failure with standard IVF or failure with one prior ICSI treatment cycle
Who cannot join
- not meeting inclusion criteria
- IVF without ICSI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center fo Reproductive Medicine
New York, New York, 10021
Rodriq Stubbs, NP, 646-962-3276, res2011@med.cornell.edu
Iman Mohammed, MPA, 646-962-3274, ibm4001@med.cornell.edu
About this study
In this proposed research study, the investigators plan to assess the efficacy of gametes' (egg and sperm) treatment on fertilization as well as pre- and post-implantation embryo development.
Read the detailed description
The spermatozoa will be prepared in the standard fashion and utilized for injection after exposure to a membrane permeabilizing agent. The raw sperm specimen may be selected through a synthetic, sterile, single-use, culture-tested mesh. The specimen will then be placed in a 37°C environment. After 30 minutes, the selected portion is retrieved from the other side of the mesh. The spermatozoa will be prepared in the standard fashion will be utilized for injection or intrauterine insemination. Human recombinant PLC-zeta will also be used if the spermatozoa have been confirmed to be PLC-zeta deficient.
The injected oocytes will be then exposed to the previously mentioned activating agents for the purpose of inducing embryo development. The successfully fertilized oocytes will be further kept in culture for up to 5 days as per standard IVF/ICSI. Results in terms of fertilization and embryo cleavage will be assessed and monitored for the remainder of the culture period. Developing embryos selected according to standard criteria will be replaced to the patient or will be cryopreserved.
Because fertilization failure carries such a high emotional and financial toll on our patients, at the present time, the only method to generate an embryo for these cases is to perform assisted oocyte activation in conjunction with ICSI. The research intervention - assisted oocyte activation - is believed to help alleviate the failed fertilization by obtaining some zygotes for the patient. In these cases of complete failed fertilization, intracytoplasmic sperm injection (ICSI) will be performed as a routine clinical treatment even if they are not enrolled in the study. After several failures, their reproductive physician may recommend the use of donor spermatozoa instead of the male partner's.
- Conditions
- Infertility
- Being tested
- gamete treatment
- Keywords
- gamete treatment, ICSI, IVF, infertility, oocyte activation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamete treatmentProcedure or surgery
Patient specimen will be selected through a synthetic, sterile, single-use, culture-tested mesh. The specimen will then be placed in a 37°C environment. After 30 minutes, the selected portion is retrieved from the other side of the mesh. The spermatozoa will be prepared in the standard fashion and utilized for injection or intrauterine insemination after exposure to a membrane permeabilizing agent. Human recombinant PLC-zeta will also be used if the spermatozoa have been confirmed to be PLC-zeta deficient. The injected oocytes will then be exposed to activating agents for the purpose of inducing embryo development. The oocyte activating agent is calcium ionophore and for sperm membrane permeabilization to assist in sperm DNA decondensation is streptolysin O (SLO).
| Study group | Role | What they receive |
|---|---|---|
| gamete treatment- oocytes and sperm | Experimental | The spermatozoa will be prepared in the standard fashion and utilized for injection after exposure to a membrane permeabilizing agent. Patient specimen will be selected through a synthetic, sterile, single-use, culture-tested mesh. The specimen will then be placed in a 37°C environment. After 30 minutes, the selected portion is retrieved from the other side of the mesh. The injected oocytes will be then exposed to the previously mentioned activating agents for the purpose of inducing embryo development. The successfully fertilized oocytes will be further kept in culture for up to 5 days as per standard IVF/ICSI. Receives: Procedure: gamete treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Efficacy of gamete treatment on fertilization
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2007
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianpiero Palermo, MD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944332
- Sponsor's protocol ID
- 0712009553
- Status last verified
- Dec 2025
- First submitted
- 8 Jul 2013
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamete Treatment to Correct Fertilization Failure
- ClinicalTrials.gov ID
- NCT01944332
- Acronym / sponsor ID
- 0712009553
- Conditions
- Infertility
- Keywords
- gamete treatment, ICSI, IVF, infertility, oocyte activation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 17 Sep 2013 (estimated)
- 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.
In this proposed research study, the investigators plan to assess the efficacy of gametes' (egg and sperm) treatment on fertilization as well as pre- and post-implantation embryo development.
Detailed description
The spermatozoa will be prepared in the standard fashion and utilized for injection after exposure to a membrane permeabilizing agent. The raw sperm specimen may be selected through a synthetic, sterile, single-use, culture-tested mesh. The specimen will then be placed in a 37°C environment. After 30 minutes, the selected portion is retrieved from the other side of the mesh. The spermatozoa will be prepared in the standard fashion will be utilized for injection or intrauterine insemination. Human recombinant PLC-zeta will also be used if the spermatozoa have been confirmed to be PLC-zeta deficient.
The injected oocytes will be then exposed to the previously mentioned activating agents for the purpose of inducing embryo development. The successfully fertilized oocytes will be further kept in culture for up to 5 days as per standard IVF/ICSI. Results in terms of fertilization and embryo cleavage will be assessed and monitored for the remainder of the culture period. Developing embryos selected according to standard criteria will be replaced to the patient or will be cryopreserved.
Because fertilization failure carries such a high emotional and financial toll on our patients, at the present time, the only method to generate an embryo for these cases is to perform assisted oocyte activation in conjunction with ICSI. The research intervention - assisted oocyte activation - is believed to help alleviate the failed fertilization by obtaining some zygotes for the patient. In these cases of complete failed fertilization, intracytoplasmic sperm injection (ICSI) will be performed as a routine clinical treatment even if they are not enrolled in the study. After several failures, their reproductive physician may recommend the use of donor spermatozoa instead of the male partner's.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gamete treatment- oocytes and sperm | Experimental | Procedure: gamete treatmentThe spermatozoa will be prepared in the standard fashion and utilized for injection after exposure to a membrane permeabilizing agent. Patient specimen will be selected through a synthetic, sterile, single-use, culture-tested mesh. The specimen will then be placed in a 37°C environment. After 30 minutes, the selected portion is retrieved from the other side of the mesh. The injected oocytes will be then exposed to the previously mentioned activating agents for the purpose of inducing embryo development. The successfully fertilized oocytes will be further kept in culture for up to 5 days as per standard IVF/ICSI. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with complete fertilization failure with standard IVF or failure with one prior ICSI treatment cycle
Key exclusion criteria (2 listed)
- not meeting inclusion criteria
- IVF without ICSI
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 |
|---|---|---|
| gamete treatmentPatient specimen will be selected through a synthetic, sterile, single-use, culture-tested mesh. The specimen will then be placed in a 37°C environment. After 30 minutes, the selected portion is retrieved from the other side of the mesh. The spermatozoa will be prepared in the standard fashion and utilized for injection or intrauterine insemination after exposure to a membrane permeabilizing agent. Human recombinant PLC-zeta will also be used if the spermatozoa have been confirmed to be PLC-zeta deficient. The injected oocytes will then be exposed to activating agents for the purpose of inducing embryo development. The oocyte activating agent is calcium ionophore and for sperm membrane permeabilization to assist in sperm DNA decondensation is streptolysin O (SLO). | Procedure or surgery | gamete treatment- oocytes and sperm |
Primary outcome
Fertilization rate
Time frame: 2 months
Efficacy of gamete treatment on fertilization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- 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.
Gianpiero Palermo, MD, MPH principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gamete treatment in people with Infertility, run by Weill Medical College of Cornell University 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodriq Stubbs, NP (646-962-3276, res2011@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate (time frame: 2 months). 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 17 Dec 2025.