Last updated on May 2018

Inovium Ovarian Rejuvenation Trials

Brief description of study

The Inovium Ovarian Rejuvenation Treatment is a PRP-based autologous treatment used in combination with a stimulated IVF sequence and Pre-Implantation Genetic Screening to treat infertility in women experiencing menopause, perimenopause, and premature ovarian failure.

Detailed Study Description

This research is being done because extensive preclinical research conducted by the member of the Inovium Scientific Advisory Board in Athens, Greece has shown strong evidence to support the efficacy of the treatment for these purposes, and has already resulted in the resumption of menses, hormone stabilization, and successful IVF, pregnancy, and conception in multiple women using only natural cycle IVF, with no stimulation. The use of stimulation (gonadotropins) and targeted pre- and posttreatment hormone monitoring within the Inovium trials is designed to optimize the successful transition of the patient from the initial treatment to IVF, pregnancy, and conception.

This study will see how the Platelet-Rich Plasma - based Inovium Ovarian Rejuvenation Treatment works to rejuvenate immune system and ovarian stem cells, restore menses, provide hormone stability, and generate successful In-Vitro Fertilization sequences, pregnancies, and conceptions. The quality of all embryos generated will be studied, with the goal of generating embryos of a premenopausal quality. Hormone stability and comprehensive biomarkers of aging and aging-related conditions will also be studied, in order to understand the extent of benefits to the physiology of the patient, and for how long these benefits can be sustained with a single treatment.

All women participating in the trial will receive the treatment. Data collected from all patients will be compared to a dataset compiled from 25 - 50 women of similar age having received like treatment via IVF and gonadotropin stimulation for positive fertility outcomes in past clinical work at the Center for Advanced Genetics, as a comparison model and substitute control group. The purpose of this comparison will be to determine overall efficacy of the Inovium Ovarian Rejuvenation Treatment as separated from the standard efficacy rates of CAG-established IVF processes and gonadotropins used in the trial.

Autologous platelet-rich plasma is manufactured using the FDA-approved Regenlab BCT-1 PRP Kit and RegenLab Drucker Centrifuge (FDA 510(k)-Approval Number BK110061 and ISO Number 13485).

Clinical Study Identifier: NCT03178695

Contact Investigators or Research Sites near you

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Eric S. Sills, M.D., PhD

Center for Advanced Genetics
Carlsbad, CA United States