PROV-ET

PROV-ET clinical research opportunity - Free IVF in Orlando, Florida

ABOUT PROV-ET

PROV-ET is a clinical research opportunity that offers a free IVF cycle (and up to two transfers) to eligible couples. This clinical research opportunity will allow us to further validate the effectiveness of Preimplantation Genetic Screening (PGS) on embryos.

You May be Eligible if:

  • You are between the age of 18 and 42
  • You have never failed an IVF cycle
  • You have an FSH level of no more than 12
  • You have an AMH level of 1 ng/mL or more
  • You have normal uterine cavity and lining
  • > 100,000 sperm on semen analysis
  • You are not pursuing IVF for a single gene disorder

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BACKGROUND

Couples undergoing In Vitro Fertilization (IVF) create embryos in hopes that the embryo transferred to the uterus will result in a live birth. To increase the chances of pregnancy, an additional screening test called Preimplantation Genetic Screening (PGS) can be performed to determine if an embryo has a normal complement of chromosomes, which can help the doctor identify which embryo to transfer.

Research has shown that PGS-diagnosed normal embryos, which contain a complete set of chromosomes, increase the chances of achieving an ongoing pregnancy, as opposed to abnormal embryos, which have additional or missing chromosomes, and are not transferred.

However, there is a small chance that the screening test result could be incorrect. A false positive result is when an embryo is diagnosed as abnormal, and therefore not transferred, but the embryo is truly normal and could have been transferred. This scenario presents a problem for all patients, but especially those who have very few or only one embryo available.

The purpose of this research study is to determine whether next generation sequencing based-PGS is able to correctly screen an embryo’s chromosomal make up.

STUDY PROCEDURE

Subjects in this study will undergo a routine IVF cycle with embryo biopsy. However, these biopsy samples will be frozen for future analysis and not used to determine which embryo to transfer. The subjects will then proceed with a frozen embryo transfer of a single, unscreened embryo selected based on morphology (how an embryo looks), which is routine.

For all participants, the biopsy will be analyzed after transfer and correlated with the participant’s clinical outcome. The results from this study will allow researchers to determine the predictive value, or accuracy, of the test – giving greater confidence about the PGS screening of embryos prior to transfer.

This study also involves some additional procedures (endometrial biopsy and aspirate, rectal and vaginal swabs collected during the egg retrieval procedure while you are under anesthesia) and blood samples. Otherwise discarded biologic samples will also be collected for the study for possible future research to determine other markers of reproductive ability.

IRB Approved at the Study Level: Sep 05, 2018.