Inovium Ovarian Rejuvenation Trials

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178695
• Other study ID #: 882388
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: April 2020
• Source: Ascendance Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility Unexplained
• Infertility, Female
• Menopause
• Menopause Premature Asymptomatic
• Menopause Premature Symptomatic
• Menopause Related Conditions
• Menopause, Premature
• Perimenopausal Disorder
• Premature Birth
• Premature Ovarian Failure
• Premature Ovarian Failure 1
• Premature Ovarian Failure 2A
• Premature Ovarian Failure 3
• Premature Ovarian Failure 4
• Premature Ovarian Failure 5
• Premature Ovarian Failure 6
• Premature Ovarian Failure 7
• Premature Ovarian Failure 8
• Premature Ovarian Failure 9
• Premature Ovarian Failure, Familial
• Primary Ovarian Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Advanced Genetics	Carlsbad	California

Sponsors (1)

Lead Sponsor	Collaborator
Ascendance Biomedical

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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: 10.1080/095 — View Citation

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

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	12 months
Secondary	Changes in Hormone Levels	Changes in hormonal levels toward normal ranges. Hormones may include FSH/LH; Estradiol/ progesterone;Inhibin; Anti- Mullerian Hormone	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	Changes in Menopausal Symptoms	A before-and-after questionnaire will be administered to collect patient personal experience data regarding changes in menopausal symptoms.	12 months

External Links

•   Clinical data (published)