Inovium Ovarian Rejuvenation Trials

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).

Inclusion Criteria:

- Signed and dated informed consent

- Women over the age of 35

- Primary or secondary amenorrhea at least for 3-6 months

- Presence of at least one ovary

- Agree to report any pregnancy to the research staff immediately.

- Willing and able to comply with study requirements.

- Willing to receive IVF to get pregnant as part of the experimental protocol.

Exclusion Criteria:

- Men will be excluded from the study.

- Current or previous IgA deficiency

- Current or previous premature ovarian failure due to a genetic origin, such as
Turner's Syndrome or chromosomal abnormality

- Current or previous great injuries or adhesions to the pelvis or ovaries

- Current and ongoing pregnancy

- Current and ongoing anticoagulant use for which plasma infusion appears
contraindicated

- Current and ongoing major Mental health disorder that precludes participation in the
study

- Current and ongoing active substance abuse or dependence

- Current and ongoing gynecological or non-gynecological cancer

- Current and ongoing chronic pelvic pain