Gamete Treatment to Correct Fertilization Failure



Status:Recruiting
Conditions:Women's Studies, Infertility
Therapuetic Areas:Reproductive
Healthy:No
Age Range:21 - 60
Updated:4/3/2019
Start Date:September 2007
End Date:November 2020
Contact:Rodriq Stubbs, NP
Email:res2011@med.cornell.edu
Phone:646-962-3276

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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.

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.

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.

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
We found this trial at
1
site
New York, New York 10021
Principal Investigator: Gianpiero Palermo, MD, PhD
Phone: 646-962-3276
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mi
from
New York, NY
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