Inovium Ovarian Rejuvenation Trials

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Infertility
Infertility Unexplained
Infertility, Female
Menopause
Menopause Premature Asymptomatic
Menopause Premature Symptomatic
Menopause Related Conditions
Menopause, Premature
Perimenopausal Disorder
Premature Birth
Premature Ovarian Failure
Premature Ovarian Failure 1
Premature Ovarian Failure 2A
Premature Ovarian Failure 3
Premature Ovarian Failure 4
Premature Ovarian Failure 5
Premature Ovarian Failure 6
Premature Ovarian Failure 7
Premature Ovarian Failure 8
Premature Ovarian Failure 9
Premature Ovarian Failure, Familial
Primary Ovarian Insufficiency

Clinical Trial Details

NCT number	NCT03178695
Study type	Interventional
Source	Ascendance Biomedical
Contact
Status	Completed
Phase	Phase 1
Start date	June 1, 2017
Completion date	May 1, 2018

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.