riogirl71 wrote:Ghost - I always wondered how safe these studies are, if it is a new drug (I saw one for new progesterone) did they do some prior research or are you the guinea pig? Does your clinic do ARC? Do they really get a discount on the regular price or is it just another kind of financing?
Yes, you would be something of a "guinea pig".
These are real discounts or truly free cycles, not just financing.
Some studies are not drug studies. Some of them compare procedures, like day 3 versus day 5 transfer, the transfer of one versus two embryos, PGD versus no PGD, or acupuncture versus a placebo. These types of studies are usually moderately discounted. You might save $1k or so in a study like this, and maybe get some free drugs, free PGD, or free acupuncture, etc.
Drug studies progress through various stages of trials in humans, all of which occur after initial trials in animals.
Phase 1 studies are small studies (20-100 healthy subjects) to test initial safety and such. These are not the trials you would ever sign up for to have a baby. If the drug passes phase 1 trials to the satisfaction of both the manufacturer and the FDA, it can then be tried in a phase 2 trial.
Phase 2 trials are moderate sized (maybe 200-300 subjects) to get an initial view of the effect of the drug, in terms of both safety and effectiveness. Again, you probably would not be in one of these. I would not recommend it to anyone here. If the drug passes a phase 2 trial, it can then be tried in a phase 3 trial.
Phase 3 trials are when they finally seek FDA approval. These are large studies, often over 1000 subjects. This is one type of study you might use to actually achieve pregnancy. They are typically designed with a new drug pitted against an existing, approved standard drug (the "control"), and patients are randomized to one or the other. These studies are usually free, including all the meds, or else are heavily discounted. They might even include free diagnostics, but not always.
Sometimes drugs go through multiple phase 3 trials, perhaps because the company seeks to get approval for a new indication, but more commonly to get approval in a different country. A drug being tested here might already be approved for use elsewhere.
Phase 4 trials are studies performed after a drug is already FDA approved and are usually sponsored by clinics, not drug companies. They might be testing the effect of the approved drug when tried in a different way or perhaps in a different population. For example, if a drug company got a progesterone product approved by testing it in fresh IVF cycles, a clinic might then investigate how well it works in FET cycles. These studies usually have a modest discount, maybe $1k in an IVF study, and will often have some free meds.
The Phase 3, Phase 4, and the procedure comparison studies are the ones to watch for. I'm not saying all of them are wonderful. But they all must involve an informed consent process, where they inform you about the study procedures, risks, and benefits, and you must be given the opportunity to ask questions and have them answered. You can withdraw from a research study at any time without penalty. You might lose the benefits of continued participation. For example, if it's a progesterone study, they won't give you any more progesterone after you withdraw from the study, but they cannot change your cycle price or charge you for the progesterone (or any other drugs) you have already received in that study just because you dropped out.
Avoid IVF and surrogacy in Ukraine. Ukrainian centers pay shills to post here under numerous sock accounts pretending to be patients in Ukraine. Centers using such deceptive advertising cannot be trusted and should be avoided.