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Inovium Ovarian Rejuvenation Trials

This study is currently recruiting participants.
Verified October 2017 by Ascendance Biomedical
Sponsor:
ClinicalTrials.gov Identifier:
NCT03178695
First Posted: June 7, 2017
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ascendance Biomedical
  Purpose
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 Intervention 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 Biological: Autologous Platelet-Rich Plasma Infusion Into Ovaries Phase 1

Study Type: Interventional
Study Design: 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 historical group of patients who have received similar interventions.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Platelet-Rich Plasma (PRP) Infusions and Biomarkers of Ovarian Rejuvenation and Aging Mitigation

Resource links provided by NLM:


Further study details as provided by Ascendance Biomedical:

Primary Outcome Measures:
  • 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.

  • 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:
  • 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.

  • 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

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 50
Actual Study Start Date: June 1, 2017
Estimated Study Completion Date: November 25, 2018
Estimated Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group
50 women will receive the Inovium Ovarian Rejuvenation Treatment.
Biological: Autologous Platelet-Rich Plasma Infusion Into Ovaries
Using FDA-approved equipment, blood plasma is received from the participant, enriched into Platelet-Rich Plasma, and infused into the ovaries.
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.

Detailed Description:

This research is being done because extensive preclinical research conducted by the member of the Inovium Scientific Advisory Board in Athens, Greece has shown strong evidence to support the efficacy of the treatment for these purposes, and has already resulted in the resumption of menses, hormone stabilization, and successful IVF, pregnancy, and conception in multiple women using only natural cycle IVF, with no stimulation. The use of stimulation (gonadotropins) and targeted pre- and posttreatment hormone monitoring within the Inovium trials is designed to optimize the successful transition of the patient from the initial treatment to IVF, pregnancy, and conception.

This study will see how the Platelet-Rich Plasma - based Inovium Ovarian Rejuvenation Treatment works to rejuvenate immune system and ovarian stem cells, restore menses, provide hormone stability, and generate successful In-Vitro Fertilization sequences, pregnancies, and conceptions. The quality of all embryos generated will be studied, with the goal of generating embryos of a premenopausal quality. Hormone stability and comprehensive biomarkers of aging and aging-related conditions will also be studied, in order to understand the extent of benefits to the physiology of the patient, and for how long these benefits can be sustained with a single treatment.

All women participating in the trial will receive the treatment. Data collected from all patients 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.

Autologous platelet-rich plasma is manufactured using the FDA-approved Regenlab BCT-1 PRP Kit and RegenLab Drucker Centrifuge (FDA 510(k)-Approval Number BK110061 and ISO Number 13485).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Aaron Traywick 971.303.9141 enrollment@inoviumrejuvenation.com
Contact: Eric S. Sills, M.D., PhD 760.994.0156

Locations
United States, California
Center for Advanced Genetics Recruiting
Carlsbad, California, United States, 92008
Contact: Eric S. Sills, M.D., PhD    760-994-0156      
Contact: Joanie Rogers    760.994.0156      
Sponsors and Collaborators
Ascendance Biomedical
Investigators
Principal Investigator: Eric S. Sills, M.D., PhD Center for Advanced Genetics
  More Information

Additional Information:
Study Data/Documents: Presentation of Preclinical Data  This link exits the ClinicalTrials.gov site
Identifier: 5688

Since late 2015, our clinicians have conducted preclinical trials using Platelet Rich Plasma (PRP) injections to rejuvenate the ovaries of menopausal women, restore fertility, and pursue pregnancy. Of the over 60 women aged 45-64 who have received the treatment so far:

Over 75% now have the option of natural pregnancy or in vitro fertilization. Over 75% have also seen overall hormone levels return to youthful levels, 9 have begun successful pregnancies. 2 have had live births.



Responsible Party: Ascendance Biomedical
ClinicalTrials.gov Identifier: NCT03178695     History of Changes
Other Study ID Numbers: 882388
First Submitted: April 19, 2017
First Posted: June 7, 2017
Last Update Posted: October 5, 2017
Last Verified: October 2017
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: No

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

Additional relevant MeSH terms:
Premature Birth
Infertility
Primary Ovarian Insufficiency
Menopause, Premature
Infertility, Female
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