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Perimenopausal DisorderPhase 1NCT03178695

Inovium Ovarian Rejuvenation Trials

A Phase 1 study testing Autologous PRP injection into human ovarian tissue in people with Perimenopausal Disorder and Menopause, run by Ascendance Biomedical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 years and older, women onlyHealthy volunteers can take part
What is being tested?
Autologous PRP injection into human ovarian tissue
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
1 Jun 2017to 1 May 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Advanced Genetics

    Carlsbad, California, 92008

Other trials in United States

About this study

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

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.

Read the 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).

Being tested
Autologous PRP injection into human ovarian tissue
Keywords
Infertility, Pregnancy, Menopause, Perimenopause, Premature Ovarian Failure
Medical subject headings
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous PRP injection into human ovarian tissueOther

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

Study groups in NCT03178695
Study groupRoleWhat they receive
Treatment GroupExperimentalPRP 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.
Receives: Other: Autologous PRP injection into human ovarian tissue
Comparison GroupNo interventionData 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

Secondary outcomes (6)

  1. Resumption of Menses

    With Premature Ovarian Failure and natural menopause the normal menstrual cycle is disrupted and normal menses does not occur. Patients will monitor for resumption of menses.

    Measured: 12 months

  2. Changes in Hormone Levels

    Changes in hormonal levels toward normal ranges. Hormones may include FSH/LH; Estradiol/ progesterone;Inhibin; Anti- Mullerian Hormone

    Measured: 12 months

  3. Changes in Egg Quality

    Using Pre-Implantation Genetic Screening, the trials will study the changes to egg quality of all eggs generated as a result of the treatment. A comparison group of patients who have received standard IVF treatment without the Inovium Ovarian Rejuvenation Treatment will be used to study this outcome.

    Measured: 12 months

  4. Changes in Health Outcomes

    Changes in overall health levels will be studied. A comparison group of patients who have received standard IVF treatment without the Inovium Ovarian Rejuvenation Treatment will be used to study this outcome. All patient data collected as described in the other outcomes will be used in this comparison.

    Measured: 12 months

  5. Duration of Identified Benefits of Treatment

    The duration of effects will be studied, in order to identify a frequency of treatment necessary to sustain positive health and fertility outcomes.

    Measured: 12 months

  6. Changes in Menopausal Symptoms

    A before-and-after questionnaire will be administered to collect patient personal experience data regarding changes in menopausal symptoms.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2017
  2. Study start1 Jun 2017
  3. Primary completion1 May 2018
  4. Study completion1 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A study group receives the intervention, which is compared in terms of efficacy against a matched group of control patients.
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03178695
Sponsor's protocol ID
882388
Status last verified
Apr 2020
First submitted
19 Apr 2017
Last updated
20 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: All requests and considerations for data sharing with individual and institutional researchers will be reviewed by the members of the Inovium Trials' Scientific Advisory Board and Primary Investigator.

Publications

  • 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.

    PubMed 30796792

  • 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.

    PubMed 29486615

  • 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.

    PubMed 32195207

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous PRP injection into human ovarian tissue in people with Perimenopausal Disorder and Menopause, run by Ascendance Biomedical at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive IVF (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03178695, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.

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