IVA Study at CCRM: Legitimate clinical trial or dubious marketing strategy?

Someone in my local Resolve support group posted this link to a new study at CCRM. They’re looking for women with Primary Ovarian Insufficiency (aka Diminished Ovarian Reserve, like me), under the age of 40. In Vitro Activation (IVA) is an invasive and relatively new technique (remove ovary tissue to treat outside the body, then reimplant and do IVF; you can find a more detailed description here, or here). I read with interest and discussed the matter with C. Given how invasive the procedure would be – presumably with risk to my already-limited fertility, C said “I bet they’d pay you a lot”. I pointed out that even if it’s just a free IVF cycle from CCRM, that would be a substantial incentive.

I was in a medical study once before – for asthma. I ended up being excluded from the study, but I did get paid $30 for an hour spent testing my lung function. The “free” methacholine challenge test they did on me showed a result in the ‘normal’ range, which proved useful when I decided, a couple years later, to get SCUBA certified.

So at minimum, I figured if I signed up for this study, I might get some free testing at CCRM…

Today I called and was told that due to the large number of callers, email was the preferred mode of contact.

So I sent an email.

And got a reply 14 minutes later (emphasis mine):

Thank you for your interest in the In Vitro Activation (IVA) Study at CCRM. The purpose of this initial email is to provide you with additional information about the study in order for you to assess your qualifications for and interest in participation. To qualify for the study you must be over 18 years old and of reproductive age, want to conceive, and have a diagnosis of primary ovarian insufficiency (POI) or diminished ovarian reserve (DOR). This means that you have clinical hormone tests that reflect a high follicle stimulating hormone (FSH) level and a low anti-Müllerian hormone (AMH), together demonstrating a reduced ovarian reserve. A rough guideline for these hormones in patients qualifying for this study are FSH over 15 mIU/mL and AMH under 0.3 ng/mL. You may be currently cycling, or experiencing amenorrhea. Those who qualify have been directed by a physician to pursue egg donation as their only option to have a child.

IVA is an intensive, experimental procedure that involves the removal of an ovary (or a portion of an ovary) laparoscopically, which is then treated outside the body with agents to potentially activate any remaining small, dormant follicles to begin growth. Portions of the ovary are then re-implanted near the fallopian tube during a second laparoscopic procedure. The patient will then be monitored bi-weekly with blood testing and ultrasound imaging. When follicle growth is detected, the follicles will be stimulated with FSH injections followed by a potential egg retrieval/IVF cycle. The process of monitoring for follicular growth and IVF cycles will be repeated for up to one year. Because of the two laparoscopies, the intensive monitoring, FSH stimulation and the potential for multiple IVF cycles, we anticipate the cost will be greater than that of a standard IVF cycle. This is difficult to estimate as it depends on each patient’s response to the experimental treatment.

If you meet study qualifications you must be a patient at CCRM in order to participate in study; therefore, a consultation with one of our physicians would first be required. If you are a new patient at CCRM they will require certain components of a fertility workup to confirm you are indeed a candidate for the study. If you are a current patient, then a regroup/IVA consult will be needed with your primary physician.

You can call CCRM’s main line at 303-788-8300 to set up a new patient consultation or regroup with a physician. For other study questions you can respond to this email regarding study criteria.

Best,

Lindsey Munkwitz, RN
Clinical Research Coordinator

So, the cost for this invasive, experimental procedure will be covered by…me?

And in order to find out whether I qualify for the study, I need to register as a patient and pay for all the preliminary tests?

I’m no expert on clinical research, but this seems a little fishy to me.

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UPDATE: After a bit more investigation, it looks like IVA is currently available in Japan (exclusively?). And if, as CCRM’s press release states, this is the first time IVA is being offered in the US, maybe it’s fair to call this a “study” while still asking the patients to pick up the tab? Still, the requirement to be an existing CCRM patient and pay for testing to even determine eligibility doesn’t sit right with me.

Anywho, my FSH is (barely) too low to qualify, and I don’t think I’m ready to eliminate the possibility of another spontaneous conception (see the last Q&A here) just to try it. So, I think I’ll pass on this “opportunity”…

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