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Ovarian Rejuvenation- The Latest News, Hype and Facts- Part Three in our Four Part Series

The topic of Ovarian Rejuvenation is the subject of this Four Part Series.  In Part One, we discussed two amazing clinical studies a few years ago which led to the discovery of how stem cells could actually reverse menopause and actually re-charge your ovaries into a state of rejuvenation.

In Part Two, we started our in-depth research into the clinics and treatment options offering this cutting-edge technology starting in the U.S. (Part Four will highlight the advancements worldwide)…Let’s continue on:

First things first, I want to thank my readers who have shared with me this information so I can broadcast it with you all.  We work best when we work together and, even with something as isolating as Infertility is, we are all here to share our journeys with one another.  Even when you feel the most alone, remember that you are not!

MORE CLINICAL TRIALS IN U.S.

One of the clinical trials I came across in my research (there aren’t but less than a handful in the U.S. currently), sounds quite promising and they state they have the success statistics to prove it.  Who are they?

The promise of Ovarian Rejuvenation offers new hope for women suffering from Premature Ovarian Failure. Here we discuss the current treatment options in this cutting edge technology…

 

Inovium Rejuventation- This innovative Clinical Research Team, led by Dr. E. Scott Sills and working in tandem with Genesis Athens Clinic in Athens, Greece (led by Dr. Konstantinos Pantos) and Dr. Pantos’ colleague, Dr. Kostas Sfakianoudis, are touting great success in not only returning ovaries to a youthful and fertile state but also actually reversing Menopause in some patients.  Yes, reversing menopause just like what the studies outlined in Part One (which were first performed on mice).

What does Inovium state about their success?

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 39-64, with the first successful patient having been in menopause for 4 years.

Menopause reversal and menstrual recovery 3-6 months post-treatment has been seen in a majority of the women, 11 of which have become pregnant through natural-cycle IVF. Approximately 2 women have given birth through IVF.”

They tout “journey-changing” results and, in this case, the clinic itself provided me actual findings from the Centre for Human Reproduction, Genesis Athens Hospital, Chalandri-Athens, Greece which led the trial.

WHAT IS THE TREATMENT?

As I discussed in Part Two with Dr. Melnick’s procedure, Inovium’s treatment also consists of the use of PRP (Platelet Rich Plasma) or PDGF (Platelet Derived Growth Factors).  To recap as I did in my previous post, this treatment consists of drawing a patient’s blood, extracting the individuals’ own white blood cells and platelets (along with Growth Factors which are already present in our blood stream and which exist naturally in order to heal both internal and external injuries) and subsequently injecting them into the patient’s ovaries.  By doing so, these Growth Factors will then affect Stem Cells (which have been shown to be present in the human ovary) in such a manner as to cause them have the ability to be transformed into new eggs or oocytes. Remember when I stated that these Stem Cells have the ability to “mimic” or “transform” into cells of wherever they are introduced?  The exact same process applies here.

This treatment by Inovium is, in a very general sense, the same as is offered by Advanced Fertility Servicesbut just as it always is in life, many differences do exist between the two.  Whereas Dr. Melnick has not presented statistics yet, Inovium claims that they have yielded great results in the process.  Why does one clinic (with seemingly the same procedure as the other) tout great success while the other does not?  When I spoke with the Team’s contact, he stated that many factors in the way the treatment is administered, in the lab, and in the method as a whole can and does affect the outcome.  No one great difference sets them apart…Regardless, their high levels of success is what intrigues me and offers me lots of hope in the success of this treatment.

INOVIUM’S CURRENT CLINICAL TRIAL 

Inovium is currently seeking candidates to participate in their clinical trials being held in Carlsbad, California.  They will be conducting these trials starting in June 2017 and are seeking 50 participants to start.  However, lets say that those 50 participation slots have been filled by the time you contact them?  Not to worry….they clearly state on their site that  “no one will be turned away”…. Yes, ladies, for those of us who have had long journeys and several IVF’s with no success, we too are eventually turned away by our own doctors or are asked to look into alternative methods.  Not so in this case.   If you meet the qualifications and are fortunate to have the funds to cover the cost of treatment, you will be accepted.

What are the steps needed to be taken and the requirements for the study?

As stated by Inovium itself:

 

“Full Process For The Inovium Ovarian Rejuvenation Treatment”:

  1. Medical records, ultrasounds, and past IVF history reviewed for confirmation.
  2. Refundable pre-enrollment deposit of $1,000 submitted to reserve space for treatment.
  3. Personal consultation with Dr. E. Thomas Sills, Primary Investigator.
  4. Following full payment, travel to Carlsbad, CA to receive one-day treatment (not included in cost unless requested).
  5. Pre-treatment hormone testing, blood draw, and blood work at off-site Carlsbad laboratory.
  6. Pre-treatment ultrasound.
  7. Delivery of the PRP-based rejuvenation treatment.
  8. Personalized recommended IVF treatment plan and gonadotropins prescription issued.
  9. Return home, with post-treatment hormone testing (bi-weekly) and blood draw/bloodwork (monthly) at local laboratory.
  10. Inovium team monitors hormone levels, notifies you when appropriate to move forward with IVF (1 -3 months)
    (These items appear optional, though recommended to increase the success of your pregnancy).
  11. Return to Carlsbad, CA where you will be the top-priority, front-of-the-line patient at our clinical facilities for your 10-14 day IVF treatment.
  12. All ultrasounds provided at no-cost.
  13. Travel and lodging not included in cost unless requested.
  14. Preimplantation Genetic Screening to analyze the quality of all eggs generated, to ensure selection of those with no chromosomal abnormalities – eggs of a pre-menopausal quality.
  15. Return home, with periodic hormone testing, blood draws, and blood work.
  16. Personalized treatment occurs throughout your pregnancy for the duration of the trial.
  17. Conception and post-conception follow-up (no travel required).

If you feel that you meet one or more of these requirements and are interested in receiving further information, you can contact Inovium through their contact form and sign up for two options.  One is with the understanding that you will follow treatment with an IVF at the Carlsbad, California clinic.  Second option- you can undergo the treatment alone without an IVF but (as was my understanding) would have to be conducted at the Genesis Athens Clinic in Athens, Greece.  I will be discussing this treatment very soon with Dr. Sills personally and will update you with any further information as soon as I do so.

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WHAT ARE THE COSTS ASSOCIATED WITH THE TREATMENT

  1. A refundable pre-enrollment deposit of $1,000 in order to ensure your slot.
  2. In-facility intra-treatment ultrasound-$525
  3. All pre- and post-treatment hormone level testing (3 months) $1,800
  4. Post-treatment hormone level monitoring (3 months) $400
  5. All blood sample analyses $2,064
  6. Administration and materials for PRP treatment $1,180
  7. Clinical support services (pre- and post-treatment counseling) $350
  8. Personalized case review and post-treatment planning $350
  9. Post-treatment report (cumulative hormonal and health benefits) $500
  10. Administrative services (scheduling, records transmission and storage) $631

Total: $7,800 (does not include travel, lodging nor IVF costs (if you opt to undergo one)

Now. let’s discuss cost if you want to undergo an IVF (typical costs range from $5,000-$20,000)…

Again, from Inovium:

“Insurance Coverage

“While the Ovarian Rejuvenation treatment itself may not be covered by your insurance provider, the cost of ultrasounds, labwork, and hormone testing likely will be.

The cost of IVF appears almost guaranteed to be covered by your insurance if you live in one of these following states:

California
Connecticut
Hawaii
Illinois
Massachusetts
New Jersey
Rhode Island

If you live in these states below, your insurance coverage likelihood may also be increased, depending upon which Affordable Care Act coverage you have selected, and if they cover the cost of infertility treatment. Your insurance may only cover in-state IVF coverage, however:

Arkansas
Louisiana
Maryland
Minnesota
Montana
New York
Ohio
Texas
Utah
West Virginia

If you do not live in those states, Dr. Sills and the Center for Advanced Genetics also appears in-network* with the following insurance companies:
Aetna
Cigna
Anthem Blue Cross
Blue Shield of California
HealthNet
Humana
United Healthcare
Tricare
*Though Dr. Sills appears considered in-network with these insurance companies, certain plans might have additional requirements. For example, your insurance company might require a referral or prior authorization before you can be seen by Dr. Sills. Neither the doctor nor the facility appear in-network with any Covered California plans. Please check with your insurance company prior to making an appointment to confirm the details specific to your plan.”

If you unfortunately don’t have insurance coverage, consider other options we outline in:

“Our Insider’s Guide to paying for an IVF”

MORE CLINICAL TRIALS IN U.S.

Continuing on in our search for Ovarian Rejuvenation treatments, I came across another clinical trial currently being undertaken in Augusta, Georgia.  Led by Study Director, Steven Levy, M.D. and his research team at Augusta University, this clinical trial began in February 2016.  As per their own provided information:

“The Rejuvenation of Premature Ovarian Failure with Stem Cells or ROSE study is open to patients with Premature Ovarian Failure of various cause from both within and outside the United States. ROSE uses treatment with autologous (patient’s own) bone marrow derived stem cells (BMSC) in an attempt to restart folliculogenesis. The endpoints include pregnancy, resumption of menses and/or normalization of hormone levels.

The study is being performed at the Augusta University Medical Center in Augusta, Georgia – location of the Medical College of Georgia, the state’s leading provider of physicians and whose areas of emphasis include regenerative medicine. MD Stem Cells is the sponsor of ROSE, Dr. Ayman Al-Hendy is the Reproductive Endocrinologist and Principal Investigator of ROSE and Dr. Steven Levy is the Study Director.”

This treatment, however, is different from the previous two I’ve highlighted.  Whereas the treatment for the others required a blood draw to extract the PRP’s, this treatment is far more invasive.  From my understanding of the process, actual stem cell material taken from the patient’s bone marrow would be extracted while patient is under anesthesia.  Following that, an assessment of the patient’s pelvic region would be performed via a Diagnostic Laparoscopy.  Finally, a biopsy of the patient’s right ovary with the introduction of the bone marrow’s stem cells would be injected directly into said ovary.

This differs greatly because it would require, in essence, two surgeries as opposed to just one (as in the extraction and then the ovarian manipulation).  Another difference I must point out is that this is in fact a clinical trial with very specific requirements to meet.  Those that the team would deem to not meet said requirements would not be accepted into the program.  Another difference between the two previous trials I mentioned.

Finally, have any study results been posted? No, unfortunately, since the clinical trial is actively recruiting participants presently and won’t publish any findings until its completion in February 2020.  To find out more, here’s a link to the study:

https://clinicaltrials.gov/ct2/show/study/NCT02696889.  

“Eligibility for the Rejuvenation of Premature Ovarian Failure with Stem Cells- ROSE Protocol” 

 

As stated on the Clinical Trial page itself:

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Inclusion Criteria:

  1. Signed and dated informed consent.
  2. Female over the age of 18.
  3. Primary or secondary amenorrhea at least for 3-6 months.
  4. Diagnosis of premature ovarian failure: At least two menopausal FSH levels (≥ 30 IU/L).
  5. Normal karyotype 46, XX.
  6. Presence of at least one ovary.
  7. Normal thyroid function as evidence by normal serum TSH levels, normal anti-microsomal antibodies.
  8. Normal prolactin level within one year of study initiation.
  9. Agree to report any pregnancy to the research staff immediately.
  10. Willing and able to comply with study requirements.
  11. Willing to attempt to get pregnant as part of the experimental protocol.
  12. No other causes of female infertility in the subject: presence of at least unilateral tubal patency (with any clinically acceptable methods), normal uterine anatomy (by any clinically and/or imaging acceptable methods).
  13. Presence of both or at least one ovary.
  14. No male infertility as evidenced by presence of normal semen analysis (>10 million sperms/ml).

Exclusion Criteria:

  1. Currently pregnant or breast-feeding.
  2. Has a history of, or evidence of current gynecologic malignancy within the past three years.
  3. Presence of adnexal masses or tenderness indicating the need for further evaluation.
  4. Major Mental health disorder that precludes participation in the study.
  5. Active substance abuse or dependence.
  6. Unfit or unwilling to undergo laparoscopy; has contraindication to laparoscopic surgery and/or general anesthesia.
  7. Current or recent (within the past 3 months) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, Herbal or botanical supplements with possible hormonal effects.
  8. Medical conditions that are contraindicated in pregnancy.
  9. Type I or Type II diabetes mellitus, or if receiving antidiabetic medications.
  10. Known significant anemia (Hemoglobin <8 g/dL).

How do I inquire further and/or submit my application for review?

First initial contact would be with Steven Levy, M.D.:  stevenlevy@mdstemcells.com or at 203-423-9494.  Once contacted, he will send out the initial requirements email (which I am providing to you here ahead of time):

“For an evaluation please email (to the address provided above) :
1) your most recent ob/gyn exam showing diagnosis of Premature Ovarian Failure.
2) blood tests that have been done to establish the diagnosis including- AMH, FSH, LH, Progesterone and Estrogen levels.
3) copy of pelvic ultrasound report (normally done for this diagnosis).
4) any other testing that may have been used to establish the diagnosis or assess infertility including Karotyping (genetic testing), HSG (Hysterosalpingogram), Semen analysis.
5) (There is also a Medical Information form which Dr. Levy will provide to you to return via email).

Once we have these, our principal investigator Dr. Al-Hendy will evaluate, determine if anything else is required and decide if you would be a candidate.”

WHAT ARE THE COSTS ASSOCIATED WITH THE TREATMENT

Here again, lies another major difference from the other two trials I’ve investigated.  Considering that this is an investigational procedure and therefore not a routinely covered expense from insurance (such as the other two discussed), all costs lie (for the most part) with the patient herself.  For this clinical trial however, the costs are exponentially higher…quoted as $33,970 for self-pay patients and for those fortunate enough to have US Healthcare insurance, the cost is $27,860.  Please also keep in mind that before any part of the procedure is performed, payment for the treatment is expected in full.  Why the huge difference in price between this procedure and the two previous ones I’ve outlined? From my discussions with the team at Inovium, the additional high costs are associated with the actual extraction of the stem cells from the patient’s bone marrow and the added cost of an additional surgery.

CONCLUSION

For those faced with Premature Ovarian Failure, these treatments seem to offer the hope that has been sorely lacking for quite some time.  Does it work? The science shows promise but it is still too new and has a lot of specialists in the field skeptical of the claims.  Of course, we want it to work and are willing to try anything to finally have success! My only advice is to tread cautiously and to make sure any and all questions are asked and answered to the best of your satisfaction.  But the eternal optimist in me says that “If you don’t at least try, you’ll never know”.

Best of luck in your next steps and if you come across any further clinical trials/studies on this innovative treatment, please feel free to contact me so I can share with the community.

 

 

 

 

 

 

 

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