Gamete Treatment for Infertility

N/A

Recruiting

Led By Gianpiero Palermo, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with complete fertilization failure with standard IVF or failure with one prior ICSI treatment cycle

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a new fertility treatment, which involves treating eggs and sperm with a special solution, is effective.

Who is the study for?

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.

What is being tested?

The study is examining the effectiveness of a special gamete treatment on egg and sperm. The goal is to see if this can improve fertilization rates and support embryo development before and after implantation in patients facing infertility issues.

What are the potential side effects?

Since the trial involves gamete treatment rather than drug administration, traditional side effects are not applicable. However, there may be risks associated with the procedures used to handle eggs and sperm which will be discussed by healthcare providers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I've had unsuccessful standard IVF or one failed ICSI cycle.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fertilization rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: gamete treatment- oocytes and spermExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met