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.

Inovium Ovarian Rejuvenation Trials

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

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).

Autologous PRP injection into human ovarian tissue

Autologous Platelet-Rich Plasma (PRP) Infusions and Biomarkers of Ovarian Rejuvenation and Aging Mitigation

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.

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.

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 hormonal levels toward normal ranges. Hormones may include FSH/LH; Estradiol/
progesterone;Inhibin; Anti- Mullerian Hormone

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 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.

The duration of effects will be studied, in order to identify a frequency of treatment
necessary to sustain positive health and fertility outcomes.

A before-and-after questionnaire will be administered to collect patient personal
experience data regarding changes in menopausal symptoms.

PRP is freshly isolated from patients with diminished ovarian reserve as determined by at
least one prior IVF cycle canceled for poor follicular recruitment response, or estimated
by serum AMH and/or FSH, no menses for ≥1 year. Immediately following substrate isolation
and activation with calcium gluconate, approximately 5 mL of autologous PRP is injected
into each ovary under direct transvaginal sonogram guidance. AMH, FSH, and serum
estradiol data will be recorded at 2wk intervals post-PRP and compared to baseline
(pre-PRP) values.

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.

Inovium Ovarian Rejuvenation Trials

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status