Clinical trial NCT03178695: Inovium Ovarian Rejuvenation Trials
Official title: Autologous Platelet-Rich Plasma (PRP) Infusions and Biomarkers of Ovarian Rejuvenation and Aging Mitigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Keywords: Infertility
Pregnancy
Menopause
Perimenopause
Premature Ovarian Failure
Lead sponsor: Ascendance Biomedical
Sponsor class: INDUSTRY
First posted: 2017-06-07
Enrollment: 200
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A study group receives the intervention, which is compared in terms of efficacy against a matched group of control patients.
Primary purpose: TREATMENT

Brief 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).

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

Primary outcomes:
measure: Positive IVF
timeFrame: 12 months
measure: Positive Pregnancy and Conception
timeFrame: 12 months
Secondary outcomes:
measure: Resumption of Menses
timeFrame: 12 months
measure: Changes in Hormone Levels
timeFrame: 12 months
measure: Changes in Egg Quality
timeFrame: 12 months
measure: Changes in Health Outcomes
timeFrame: 12 months
measure: Duration of Identified Benefits of Treatment
timeFrame: 12 months
measure: Changes in Menopausal Symptoms
timeFrame: 12 months
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Center for Advanced Genetics
state: California
Study officials:
affiliation: Center for Advanced Genetics (CAG)
name: E Scott Sills, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sills ES, Rickers NS, Petersen JL, Li X, Wood SH. Regenerative effect of intraovarian injection of activated autologous platelet rich plasma: Serum anti-Mullerian hormone levels measured among poor-prognosis in vitro fertilization patients. International Journal of Regenerative Medicine 2020;3(1):1-5. https://www.sciencerepository.org/regenerative-effect-of-intraovarian-injection_RGM-2020-1-102
citation: Sills ES, Li X, Rickers NS, Wood SH, Palermo GD. Metabolic and neurobehavioral response following intraovarian administration of autologous activated platelet rich plasma: First qualitative data. Neuro Endocrinol Lett. 2019 Jan;39(6):427-433.
citation: Sills ES, Rickers NS, Li X, Palermo GD. First data on in vitro fertilization and blastocyst formation after intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. Gynecol Endocrinol. 2018 Sep;34(9):756-760. doi: 10.1080/09513590.2018.1445219. Epub 2018 Feb 28.
citation: Sills ES, Rickers NS, Svid CS, Rickers JM, Wood SH. Normalized Ploidy Following 20 Consecutive Blastocysts with Chromosomal Error: Healthy 46, XY Pregnancy with IVF after Intraovarian Injection of Autologous Enriched Platelet-derived Growth Factors. Int J Mol Cell Med. 2019 Winter;8(1):84-90. doi: 10.22088/IJMCM.BUMS.8.1.84. Epub 2019 May 15.