Clinical trial NCT01944332: Gamete Treatment to Correct Fertilization Failure
Official title: Gamete Treatment to Correct Fertilization Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Keywords: gamete treatment
ICSI
IVF
infertility
oocyte activation
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 1200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fertilization rate
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Center fo Reproductive Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Gianpiero Palermo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: