Recruiting

Gamete Treatment

Sponsor:

Weill Medical College of Cornell University

Code:

NCT01944332

Conditions

Infertility

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

gamete treatment

Study Details

Brief 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.

Conditions

Infertility

Study ID

NCT01944332

Start date

Sep, 2007

Status verified date

Dec, 2025

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with complete fertilization failure with standard IVF or failure with one prior ICSI treatment cycle

Exclusion Criteria:

  • not meeting inclusion criteria
  • IVF without ICSI

Study Design

Enrollment

1200 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: gamete treatment- oocytes and sperm

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.

Interventions

gamete treatment

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).

Primary outcome measure

  • Fertilization rate [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Rodriq Stubbs, NP

646-962-3276res2011@med.cornell.edu

Iman Mohammed, MPH

646-962-3274ibm4001@med.cornell.edu

Locations

Center fo Reproductive Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Rodriq Stubbs, NP

646-962-3276res2011@med.cornell.edu

Iman Mohammed, MPA

646-962-3274ibm4001@med.cornell.edu

Principal Investigator:

Gianpiero Palermo, MD, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • gamete treatment
  • ICSI
  • IVF
  • infertility
  • oocyte activation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-12-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.