inovium ovarian rejuvenation trials

Conditions: 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

Summary: 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).

Eligibility criteria:
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

Keywords: infertility pregnancy menopause perimenopause premature ovarian failure