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.
This research extends earlier work conducted by Inovium associates in Athens, Greece who demonstrated efficacy of intraovarian injection of autologous PRP for resumption of menses, hormone stabilization, and conception after IVF in multiple women following PRP+natural cycle IVF (i.e., without gonadotropin stimulation). The use of stimulation (gonadotropins) and targeted pre- and posttreatment hormone monitoring during this clinical trial aims to characterize more fully the transition from PRP dosing, embryogenesis, IVF and conception. The current study seeks to describe how PRP works to rejuvenate immune system and ovarian stem cells, restore menses, provide hormone stability, and generate successful IVF sequences and conceptions. The quality of all embryos generated will be studied via PGS, with the goal of generating euploid embryos. Hormone stability and biomarkers of aging will also be evaluated to understand the extent of any observed benefits, and to estimate how long such effects may be sustained with a single PRP treatment. Autologous activated PRP used in this clinical study is isolated from patient derived (blood) samples collected on-site, using FDA-approved Regenlab \[Lausanne, Switzerland\] BCT-1 PRP Kit and RegenLab Drucker Centrifuge (FDA 510(k)-Approval #BK110061; ISO#13485).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Using FDA-approved equipment, blood plasma is received from participant, isolated/enriched into PRP, and infused into the ovaries under transvaginal ultrasound guidance.
Center for Advanced Genetics
Carlsbad, California, United States
Positive IVF
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.
Time frame: 12 months
Positive Pregnancy and Conception
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.
Time frame: 12 months
Resumption of Menses
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.
Time frame: 12 months
Changes in Hormone Levels
Changes in hormonal levels toward normal ranges. Hormones may include FSH/LH; Estradiol/ progesterone;Inhibin; Anti- Mullerian Hormone
Time frame: 12 months
Changes in Egg Quality
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.
Time frame: 12 months
Changes in Health Outcomes
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.
Time frame: 12 months
Duration of Identified Benefits of Treatment
The duration of effects will be studied, in order to identify a frequency of treatment necessary to sustain positive health and fertility outcomes.
Time frame: 12 months
Changes in Menopausal Symptoms
A before-and-after questionnaire will be administered to collect patient personal experience data regarding changes in menopausal symptoms.
Time frame: 12 months
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