Gamete Treatment to Correct Fertilization Failure

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Procedure: gamete treatment

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 Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodriq Stubbs, NP; Phone Number: 646-962-3276; Email: res2011@med.cornell.edu
• Study Contact Backup: Name: Iman Mohammed, MPH; Phone Number: 646-962-3274; Email: ibm4001@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Center fo Reproductive Medicine
      • Contact: Rodriq Stubbs, NP; Phone Number: 646-962-3276; Email: res2011@med.cornell.edu
      • Contact: Iman Mohammed, MPA; Phone Number: 646-962-3274; Email: ibm4001@med.cornell.edu
      • Principal Investigator: Gianpiero Palermo, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization rate	Efficacy of gamete treatment on fertilization	2 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Gianpiero Palermo, MD, MPH, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2007
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimated): September 17, 2013

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: IVF; infertility; ICSI; oocyte activation; gamete treatment
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 0712009553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO