NCT03178695

Inovium Ovarian Rejuvenation Trials

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Ascendance Biomedical · Industry
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

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).

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

Interventions

Type	Name	Description
OTHER	Autologous PRP injection into human ovarian tissue	Using FDA-approved equipment, blood plasma is received from participant, isolated/enriched into PRP, and infused into the ovaries under transvaginal ultrasound guidance.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2017-06-07
• Last updated: 2020-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study