Gamete Treatment to Correct Fertilization Failure

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT01944332
Status
Recruiting
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Conditions

  • Infertility

Eligibility Criteria

Sex
ALL
Age
21 Years - 89 Years
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
Sep 30, 2007
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
1,200 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Fertilization rate [ Time Frame: 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center fo Reproductive MedicineNew YorkNew York10021
Rodriq Stubbs, NP
[email protected]
646-962-3276
Iman Mohammed, MPA
[email protected]
646-962-3274
Gianpiero Palermo, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Center fo Reproductive Medicine· New York, NY

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