Gamete Treatment to Correct Fertilization Failure

NCT01944332 | Recruiting

• 1 other identifier: 0712009553
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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

Keywords

gamete treatment; ICSI; IVF; infertility; oocyte activation

Outcome Measures

Primary Outcomes (1)

• Fertilization rate

  Efficacy of gamete treatment on fertilization

  2 months

Study Arms (1)

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.

Procedure: gamete treatment

Interventions

gamete treatment PROCEDURE

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).

gamete treatment- oocytes and sperm

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• IVF without ICSI

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Center fo Reproductive Medicine

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Gianpiero Palermo, MD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodriq Stubbs, NP

CONTACT

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

Iman Mohammed, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2007
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)