Inovium Ovarian Rejuvenation Trials
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03178695|
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : May 22, 2018
|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|
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|
|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)|
|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|
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.
- 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.
- 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.
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
|United States, California|
|Center for Advanced Genetics|
|Carlsbad, California, United States, 92008|
|Principal Investigator:||E Scott Sills, MD PhD||Center for Advanced Genetics (CAG)|