Inovium Ovarian Rejuvenation Trials

NCT03178695 | Completed Phase 1 DMC FDA Device

• 1 other identifier: 882388
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Positive IVF

  Following the initial Ovarian Rejuvenation Treatment, subjects will undergo IVF treatment to test the efficacy of the Protocol for fertility outcomes, as per trial protocols.

  12 months

• Positive Pregnancy and Conception

  Following completion of trial protocols, patients will conduct ongoing post-treatment follow-up with trial staff for recording progress of all ongoing pregnancies and conceptions, via post-treatment correspondence.

  12 months

Secondary Outcomes (6)

• Resumption of Menses

  12 months

• Changes in Hormone Levels

  12 months

• Changes in Egg Quality

  12 months

• Changes in Health Outcomes

  12 months

• Duration of Identified Benefits of Treatment

  12 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Other: Autologous PRP injection into human ovarian tissue

Comparison Group

NO INTERVENTION

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.

Interventions

Autologous PRP injection into human ovarian tissue OTHER

Using FDA-approved equipment, blood plasma is received from participant, isolated/enriched into PRP, and infused into the ovaries under transvaginal ultrasound guidance.

Treatment Group

Eligibility Criteria

• Age: 35 Years+
• Gender Eligibility Details: Men are not eligible to participate in the trials.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascendance Biomedical: lead

Study Sites (1)

Center for Advanced Genetics

Carlsbad, California, 92008, United States

Location

Related Publications (4)

• 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

  RESULT

• 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.

  PMID: 30796792 RESULT

• 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.

  PMID: 29486615 RESULT

• 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.

  PMID: 32195207 RESULT

Related Links

• Clinical data (published)

MeSH Terms

Conditions

Menopause, Premature; Primary Ovarian Insufficiency; Premature ovarian failure, familial; Premature Ovarian Failure 2a; Premature Ovarian Failure 3; Ovarian Dysgenesis 2; Premature Ovarian Failure 5; Premature Ovarian Failure 6; Premature Ovarian Failure 7; Infertility; Infertility, Female

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• E Scott Sills, MD PhD

  Center for Advanced Genetics (CAG)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A study group receives the intervention, which is compared in terms of efficacy against a matched group of control patients.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: June 7, 2017
• Study Start: June 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)