Do I qualify to participate in the trials?
While all women qualify to receive the treatment and no woman will be turned away, not all women qualify to participate in the actual trial, which is limited to 50 women. Preference and expedited treatment is given to perimenopausal and menopausal women who have undertaken at least one failed IVF cycle in the last two years, and can commit to a full IVF process at our clinical facility in Carlsbad, CA.
No woman will be turned away who wants to receive the treatment. Please complete the application form here, and we will find a way to help.
Why do women have to commit to a full IVF cycle to participate in the trial?
The short answer is that in order to show the best possible results, every woman’s treatment must be standardized. After you receive treatment, we will be monitoring your hormone response via a laboratory in your area every two weeks – as soon as we see a hormonal change, we have to get you back to Carlsbad and begin the IVF process immediately. You will go to the front of the line at our Carlsbad facility and receive the highest and most expedient standard of care and treatment planning.
The long answer is that even though we know this treatment works for menopause reversal, it has not worked for all women – this is because the majority of women who have received the treatment have not stayed with one IVF facility for the entirety of their cycle. Improper communication between the administrators of the ovarian rejuvenation treatment and a lack of understanding of the treatment from most local IVF centers leads to non-scientific and inconclusive data – the solution is to standardize IVF treatment at one, single facility, in order to maximize potential pregnancies for our participants.
What if I want to receive the ovarian rejuvenation treatment and pursue my IVF elsewhere – or if I want to try for a natural intercourse pregnancy?
Again, no woman will be turned away.
You will not be able to participate in the pilot trials, but you will be able to receive the treatment used in the trials here in the U.S.
Comprehensive monitoring and analysis as described above will be included, and we will notify you when your cycle is returning, so that you can take action immediately. You will be provided with treatment records to share with your local IVF facility. You will not receive a cytological survey to assist in the selection of the best possible eggs for using in the IVF cycle.
What is the goal of the Inovium Ovarian Rejuvenation Trials?
Our goal in the U.S.-based, California pilot trials is to expedite the original menopause reversal technique as developed by our partners in Greece to that to 3 months or less, in conjunction with the medical research and clinical team listed on this site.
We have a primary focus in studying AMH changes, and will also look at FSH. Hormonal changes will be a focus, though please do understand, we will be focusing on oocyte (ovarian stem cell rejuvenation) as a result of the treatment.Oocyte rejuvenation appears as the core structural process resulting in follicle, ovarian, and hormonal restoration – not just to menstration, but to optimal fertility levels of supercentenarian women.
Supercentenarian women – women who live to the age of 100 or beyond – all enter menopause at a much later year than most women, and have high levels of natural fertility (fecundity) throughout life.
Our goal is to bring the patient to their level of relative health – however temporary – in order to best proceed with pregnancy.
We will focus on the generation of as many eggs as possible through just one treatment and one menstrual cycle, in order to maximize the selection of healthy eggs lacking chromosomal damage, such as predilection to Down’s Syndrome, as typically seen by women of older years. Other high-interest research areas include the impact of the treatment on mitigating predisposition towards various age-related diseases and conditions that occur at the onset of menopause.
What did the original research show?
Since late 2015, preclinical trials data collected in 60+ patients has proven initial post-treatment restoration of Follicle Stimulating Hormone, Luteinizing Hormone, Estradiol, and Anti-Mullerian Hormone to youthful levels at one, two, and three months post-treatment in over 75% of patients. All patients are perimenopausal and menopausal, aged 45-64, with the first successful patient having been in menopause for 4 years. Multiple pregnancies and conceptions have occurred; view this page for more details.
What costs are included in the trial?
The cost of all labworks at our Carlsbad facility and when you return to your local area, cytological monitoring, clinical consultations, treatment, blood draws, gonadotropins, IVF treatment and planning, and pre- and post-treatment lab analysis of hormone and blood-based biomarkers of health and aging-related conditions.
The cost of ovarian rejuvenation treatment appears as roughly $5-$7,500, and the cost of IVF roughly $15 – $20,000.
All ultrasounds will be provided free of charge, and are not represented in the cost of treatment. While rare, any additional ovarian rejuvenation treatments needed will also be provided at no-cost.
24/7 on-demand support from our clinical research team is also provided as a free service to all patients, in order to minimize any stress while waiting for lab reports and menstration to resume.
Flights and hotel accommodations in Carlsbad can be included in the cost as requested.
What costs are included if I only want to receive the ovarian rejuvenation treatment?
The cost of treatment, all clinical consultations, pre- and post-treatment lab analysis of hormone and blood-based biomarkers of health and aging-related conditions, and immediate post-treatment notification when you should proceed to your local IVF facility.
To expedite results for your treatment, the costs of comprehensive post-treatment labwork can be included, averaging $500 per month for less than 3 months’ time.
You will only need to travel to our Carlsbad facility once.
Will my insurance cover this?
We work with all insurers, though participants should not depend on this, as this is neither a traditional or locally-available treatment.
If your insurance specifically provides coverage for IVF treatment, then we will likely be able to cover 75% or more of your costs in the trial.
Do you have a financing plan?
Yes, we work with Prosper for participant co-financing options. Prosper can be used to pay for 100% of your costs, including travel, lodging, and meals.
How does your therapy work?
Through PRP (Platelet Rich Plasma) injections of the patient’s own genetic material into her ovaries. Unlike traditional PRP transfusions, no donor is needed – instead, the patient’s own genetic material is used to heal the body. The basic process involves the removal of the patient’s own blood plasma, enrichment via centrifuge, and re-injection into the ovaries without the use of any additional substances.
Could I get this treatment done at any fertility clinic around the world?
We do not advise this, for reasons of both safety and success of the treatment. Currently, only one other clinic that we know of provides ovarian rejuvenation, and they have not been able to replicate the success of our researchers.
PRP transfusions are a diverse medical field – the percentage and combination of different platelet counts and the equipment used to transform the blood plasma into PRP is not standard across the medical field. For this reason, success rates are also not consistent with our results, and we cannot confirm the safety of other clinics attempting to conduct ovarian rejuvenation.
Finally, there is a diversity of different equipment used to transform blood plasma into PRP – and the vast majority of this equipment is notapproved as safe for patient use in clinical trials or clinical treatment by the FDA or other national regulatory bodies. Our equipment is approved by and confirmed to be safe for use in patients by the FDA and the European Union’s Council of Competent Authorities.
Why are the ovarian rejuvenation techniques employed by Inovium’s researchers successful, where others are not?
Through careful and deliberate preclinical research with over 60 patients over a year’s time, our researchers were able to accurately define:
- – the best equipment for use in turning our patients’ blood plasma into PRP
- – the proper platelet counts and concentrations for the PRP
- – the differing procedures required to ensure that women of all levels of ovarian deterioration can benefit from the treatment
Through these practices, our researchers were able to obtain a higher than 75% success rate for all patients treated during these preclinical trials.
Are PRP transfusions safe?
Yes – uniquely safe, according to the FDA and the EU’s Council of Competent Authorities. In the EU and US, PRP transfusions are regarded as one of the safest possible treatments, and are used in the treatment of a variety of conditions. Unlike treatments that use hormones, stem cell technology, or pharmaceuticals, blood transfusions require only limited oversight to ensure safety.
In the case of our treatments, since only the patient’s own blood is used, we have an even higher level of safety, since the patient is not receiving blood from a donor that would have to be pre-screened for potential diseases.
I don’t understand. How can my own blood be used to heal my body?
PRP as a whole has been extremely popular in sports medicine, where it is frequently used by athletes to increase muscular repair. We are essentially applying these same principles in our trials, to evaluate the potential for long-term treatment for menopause, infertility, and the damaging age-related conditions that affect women in menopause.
While most people only ever receive a blood transfusion in an emergency, a PRP donation can be used to facilitate healing and rejuvenation within the body at any time. This is due to the presence of natural growth factors within blood, which are increased when a blood donation is enriched via centrifuge, and turned into PRP.
When will the trials begin?
The Inovium Ovarian Rejuvenation Trials will begin in June of 2017, with a limited enrollment of 50 patients at our primary clinic in Carlsbad, California.
The Ovarian Rejuvenation treatment itself is available currently for a select group of women. Please fill out our “Pre-Enrollment Interest Form” if you would like to learn more.
Our researchers and clinicians maintain a large and professional medical team from a diversity of medical disciplines and have successfully treated women for infertility for over 10 years.