Study Results
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Basic Information
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COMPLETED
PHASE1
200 participants
INTERVENTIONAL
2017-06-01
2018-05-01
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group
PRP is freshly isolated from patients with diminished ovarian reserve as determined by at least one prior IVF cycle canceled for poor follicular recruitment response, or estimated by serum AMH and/or FSH, no menses for ≥1 year. Immediately following substrate isolation and activation with calcium gluconate, approximately 5 mL of autologous PRP is injected into each ovary under direct transvaginal sonogram guidance. AMH, FSH, and serum estradiol data will be recorded at 2wk intervals post-PRP and compared to baseline (pre-PRP) values.
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.
Comparison Group
Data collected from all patients in the Treatment Group will be compared to a dataset compiled from 25 - 50 women of similar age having received like treatment via IVF and gonadotropin stimulation for positive fertility outcomes in past clinical work at the Center for Advanced Genetics, as a comparison model and substitute control group. The purpose of this comparison will be to determine overall efficacy of the Inovium Ovarian Rejuvenation Treatment as separated from the standard efficacy rates of CAG-established IVF processes and gonadotropins used in the trial.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
FEMALE
Yes
Sponsors
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Ascendance Biomedical
INDUSTRY
Responsible Party
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Principal Investigators
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E Scott Sills, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Center for Advanced Genetics (CAG)
Locations
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Center for Advanced Genetics
Carlsbad, California, United States
Countries
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References
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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
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.
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.
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.
Related Links
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Clinical data (published)
Other Identifiers
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882388
Identifier Type: -
Identifier Source: org_study_id
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