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Inovium Ovarian Rejuvenation Trials

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ClinicalTrials.gov Identifier: NCT03178695
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Ascendance Biomedical

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.

Condition or disease Intervention/treatment Phase
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 Other: Autologous PRP injection into human ovarian tissue Phase 1

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Autologous Platelet-Rich Plasma (PRP) Infusions and Biomarkers of Ovarian Rejuvenation and Aging Mitigation
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018


Arm Intervention/treatment
Experimental: 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.
Other: 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.

No Intervention: 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.



Primary Outcome Measures :
  1. Positive IVF [ Time Frame: 12 months ]
    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.

  2. Positive Pregnancy and Conception [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Resumption of Menses [ Time Frame: 12 months ]
    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.

  2. Changes in Hormone Levels [ Time Frame: 12 months ]
    Changes in hormonal levels toward normal ranges. Hormones may include FSH/LH; Estradiol/ progesterone;Inhibin; Anti- Mullerian Hormone

  3. Changes in Egg Quality [ Time Frame: 12 months ]
    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.

  4. Changes in Health Outcomes [ Time Frame: 12 months ]
    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.

  5. Duration of Identified Benefits of Treatment [ Time Frame: 12 months ]
    The duration of effects will be studied, in order to identify a frequency of treatment necessary to sustain positive health and fertility outcomes.

  6. Changes in Menopausal Symptoms [ Time Frame: 12 months ]
    A before-and-after questionnaire will be administered to collect patient personal experience data regarding changes in menopausal symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men are not eligible to participate in the trials.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178695


Locations
United States, California
Center for Advanced Genetics
Carlsbad, California, United States, 92008
Sponsors and Collaborators
Ascendance Biomedical
Investigators
Principal Investigator: E Scott Sills, MD PhD Center for Advanced Genetics (CAG)

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 5688
This investigation extends PRP application to ovarian tissue with a view to document impact on ovarian reserve among women attending for infertility treatment. While autologous PRP has been successfully applied therapeutically to various tissues to accelerate healing and wound repair, this is the first description of direct injection of activated PRP into the human ovary of poor prognosis IVF patients. Evidence of improved ovarian function was noted in all who received intraovarian PRP, possibly as early as two months after treatment. Additional research is needed to clarify which PRP components are responsible for altered ovarian function.

Responsible Party: Ascendance Biomedical
ClinicalTrials.gov Identifier: NCT03178695     History of Changes
Other Study ID Numbers: 882388
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Ascendance Biomedical:
Infertility
Pregnancy
Menopause
Perimenopause
Premature Ovarian Failure

Additional relevant MeSH terms:
Premature Birth
Infertility
Infertility, Female
Primary Ovarian Insufficiency
Menopause, Premature
Genetic Diseases, X-Linked
Gonadal Dysgenesis
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Genetic Diseases, Inborn
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities