anyone done a clinical research study?

kthappy76

I'm meeting my endo surgeon for the 1st time tomorrow and he already left a msg. to recruit me to join a clinical research study that he is doing on gene/hormone markers for endo & pain. 

Have you participated in any kind of study like this? 

I generally favor teaching hospitals and put up with all sorts of extra people in the room so that they can learn, but I'm a little put off by the fact that the consent form says that if I suffer complications, I/my insurance would be responsible for costs...  (and compensation is very minimal)

ams8099

I did a PCOS IVF study. They wanted to compare protocols and see if one was more likely to cause OHSS in PCOS patients. It wasn't FCI's study per say, Ferring Pharmaceuticals was running the study and they were using FCI patients.

I got 50% off my cycle, which made it possible for me to do IVF since we are 100% OOP.  I also got one med for free (estrodial...big deal) and $100 of my med cost. 

I don't really remember if there was anything about the insurance. But I think that is pretty standard.

kthappy76

ams8099:

I did a PCOS IVF study. They wanted to compare protocols and see if one was more likely to cause OHSS in PCOS patients. It wasn't FCI's study per say, Ferring Pharmaceuticals was running the study and they were using FCI patients.

I got 50% off my cycle, which made it possible for me to do IVF since we are 100% OOP.  I also got one med for free (estrodial...big deal) and $100 of my med cost. 

I don't really remember if there was anything about the insurance. But I think that is pretty standard.

Amber, now that is a sweet study.  This one sounds a little more of the altruistic variety.  Hope to learn more tomorrow...

BunnyintheYard

If it's for genes and hormone markers, would it just involve extra blood draws or vials of blood at your regular draws?  Or are there other aspects of it?  If it were invasive in a surgical setting or required other invasive or time consuming procedures, I would look to the compensation and be sure they will pay for injury.  But if it is just a couple of extra vials, or something simple like that, it's standard legal text in your consent that the sponsor won't compensate for injuries.

Good luck!

kthappy76

BunnyintheYard:

If it's for genes and hormone markers, would it just involve extra blood draws or vials of blood at your regular draws?  Or are there other aspects of it?  If it were invasive in a surgical setting or required other invasive or time consuming procedures, I would look to the compensation and be sure they will pay for injury.  But if it is just a couple of extra vials, or something simple like that, it's standard legal text in your consent that the sponsor won't compensate for injuries.

Good luck!

It's a blood draw, uterine biopsy (during surgery), pelvic exam, and an optional pressure pain threshold test.

baloneydisc

I am currently doing a PCOS Research Study.  Granted it's not as big of a deal as the one you're doing or the other one that was mentioned.  It's to compare the results using Clomid & Femara to try & get Femara FDA approved for use in inducing ovulation.

Anyhow, there is no compensation for the study, but it includes everything.  The study is for 6-months.  They paid for my SHG, DH's SA & all of the meds, b/w & u/s for the duration of the study.  If we end up pregnant we have the option of allowing them to "shadow" us for a couple of years to see if there are any complications of the meds to our child.

There was nothing in my paperwork about insurance.  When I went for my initial appointment they said they did not even need my insurance information unless we also wanted our b/w sent off for HIV & other STD testing.

Please let me know if you're interested in any more information about what my consent forms said.

kthappy76

elainelbuck:

I am currently doing a PCOS Research Study.  Granted it's not as big of a deal as the one you're doing or the other one that was mentioned.  It's to compare the results using Clomid & Femara to try & get Femara FDA approved for use in inducing ovulation.

Anyhow, there is no compensation for the study, but it includes everything.  The study is for 6-months.  They paid for my SHG, DH's SA & all of the meds, b/w & u/s for the duration of the study.  If we end up pregnant we have the option of allowing them to "shadow" us for a couple of years to see if there are any complications of the meds to our child.

There was nothing in my paperwork about insurance.  When I went for my initial appointment they said they did not even need my insurance information unless we also wanted our b/w sent off for HIV & other STD testing.

Please let me know if you're interested in any more information about what my consent forms said.

That sounds like a great study!  And thanks for the info.  Best of luck!

bhead81

I did one for annovulation.  I tested a electronic method for delivery of IF meds instead of injectibles.  Meds and testing were covered at 100%, even H's SA.  They also paid $500 so it was well worth it.  We ended up with a BFN but we got some testing done on H without having to pay for it.

KiKiGee

We're at the tail end of an IVF study comparing fresh and frozen transfer rates. We saved nearly 1/2 of the cost of the cycle (when I take into consideration the free meds).

It's been great for us, because we trust our RE and figured that if we got randomized to fresh it would be a regular IVF and if we got randomized to frozen (we did) then it might be *better* b/c that was the hypothesis of our RE.

We find out Saturday...... eeeeeeeekkkkkk......