Inovium Ovarian Rejuvenation Trials
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|ClinicalTrials.gov Identifier: NCT03178695|
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : October 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Perimenopausal Disorder Menopause Menopause, Premature Menopause Related Conditions Menopause Premature Symptomatic Menopause Premature Asymptomatic Premature Ovarian Failure Premature Ovarian Failure, Familial Premature Ovarian Failure 2A Premature Ovarian Failure 3 Premature Ovarian Failure 4 Premature Ovarian Failure 1 Premature Ovarian Failure 5 Premature Ovarian Failure 6 Premature Ovarian Failure 7 Premature Ovarian Failure 9 Premature Ovarian Failure 8 Infertility Infertility, Female Infertility Unexplained||Biological: Autologous Platelet-Rich Plasma Infusion Into Ovaries||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A study group receives the intervention, which is compared in terms of efficacy against a historical group of patients who have received similar interventions.|
|Masking:||None (Open Label)|
|Official Title:||Autologous Platelet-Rich Plasma (PRP) Infusions and Biomarkers of Ovarian Rejuvenation and Aging Mitigation|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||August 1, 2018|
|Estimated Study Completion Date :||November 25, 2018|
Experimental: Treatment Group
50 women will receive the Inovium Ovarian Rejuvenation Treatment.
Biological: Autologous Platelet-Rich Plasma Infusion Into Ovaries
Using FDA-approved equipment, blood plasma is received from the participant, enriched into Platelet-Rich Plasma, and infused into the ovaries.
No Intervention: Comparison Group
Data collected from all patients in the Treatment Group 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.
- Positive IVF [ Time Frame: 12 months ]Following the initial Ovarian Rejuvenation Treatment, subjects will undergo IVF treatment to test the efficacy of the Protocol for fertility outcomes, as per trial protocols.
- Positive Pregnancy and Conception [ Time Frame: 12 months ]Following completion of trial protocols, patients will conduct ongoing post-treatment follow-up with trial staff for recording progress of all ongoing pregnancies and conceptions, via post-treatment correspondence.
- Resumption of Menses [ Time Frame: 12 months ]With Premature Ovarian Failure and natural menopause the normal menstrual cycle is disrupted and normal menses does not occur. Patients will monitor for resumption of menses.
- Changes in Hormone Levels [ Time Frame: 12 months ]Changes in hormonal levels toward normal ranges. Hormones may include FSH/LH; Estradiol/ progesterone;Inhibin; Anti- Mullerian Hormone
- Changes in Egg Quality [ Time Frame: 12 months ]Using Pre-Implantation Genetic Screening, the trials will study the changes to egg quality of all eggs generated as a result of the treatment. A comparison group of patients who have received standard IVF treatment without the Inovium Ovarian Rejuvenation Treatment will be used to study this outcome.
- Changes in Health Outcomes [ Time Frame: 12 months ]Changes in overall health levels will be studied. A comparison group of patients who have received standard IVF treatment without the Inovium Ovarian Rejuvenation Treatment will be used to study this outcome. All patient data collected as described in the other outcomes will be used in this comparison.
- Duration of Identified Benefits of Treatment [ Time Frame: 12 months ]The duration of effects will be studied, in order to identify a frequency of treatment necessary to sustain positive health and fertility outcomes.
- Changes in Menopausal Symptoms [ Time Frame: 12 months ]A before-and-after questionnaire will be administered to collect patient personal experience data regarding changes in menopausal symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178695
|Contact: Aaron Traywickemail@example.com|
|Contact: Eric S. Sills, M.D., PhD||760.994.0156|
|United States, California|
|Center for Advanced Genetics||Recruiting|
|Carlsbad, California, United States, 92008|
|Contact: Eric S. Sills, M.D., PhD 760-994-0156|
|Contact: Joanie Rogers 760.994.0156|
|Principal Investigator:||Eric S. Sills, M.D., PhD||Center for Advanced Genetics|