Gamete Treatment for Infertility
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is Gamete Treatment for Infertility safe for humans?
Assisted reproduction techniques, which include treatments like Gamete Treatment, have some safety concerns. These include risks of multiple pregnancies, potential long-term effects on women and children, and complications like ovarian hyperstimulation syndrome. While some drugs used in these treatments may have side effects, efforts are made to minimize risks, and no treatment is entirely risk-free.12345
How is Gamete Treatment different from other infertility treatments?
Gamete Treatment is unique because it involves assisted activation of oocytes (egg cells) and can be used in cases where traditional sperm injection methods fail, such as with globozoospermia (a condition where sperm have round heads and cannot activate the egg). This treatment specifically targets the activation process, which is not addressed by standard treatments.678910
What data supports the effectiveness of the Gamete Treatment for Infertility?
The research on improving outcomes for poor responders in IVF (in vitro fertilization) suggests that strategies like accumulating embryos over multiple cycles and optimizing ovarian stimulation can enhance treatment success. These approaches may indirectly support the effectiveness of Gamete Treatment by improving embryo quality and increasing the chances of successful pregnancy.1112131415
Who Is on the Research Team?
Gianpiero Palermo, MD, MPH
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for individuals who have experienced complete fertilization failure with standard IVF or those who have had one unsuccessful ICSI treatment cycle. It's not open to people who don't meet these specific conditions, or those who have only tried IVF without ICSI.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Gamete Treatment
Spermatozoa are prepared and utilized for injection after exposure to a membrane permeabilizing agent. Oocytes are exposed to activating agents to induce embryo development.
Culture and Assessment
Successfully fertilized oocytes are kept in culture for up to 5 days, and embryo development is monitored.
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on fertilization rate and embryo development.
What Are the Treatments Tested in This Trial?
Interventions
- Gamete Treatment
Gamete Treatment is already approved in European Union, United States, Canada for the following indications:
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Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor