Afolia clinical trial


#1

Anyone gotten any info on the phase lll trial afolia vs gonal f in women 35 to 42. I believe main location is NY but I heard its going be in Texas too! Should start recruiting in about 6 weeks or so and I read there would be over 1000 people recruited.


#2

I called and was told that this trial will be in 25 Locations. That’s all the information that they would give.


#3

Is the trail for IVF? I am 40 and looking to have another round. Who did you call to get the 25 locations info? Where can we find more info about it all?


#4

trial

Yea I haven’t been able to get much info either. I know 2 locations are ny and Dallas. I believe recruitment starts in or around July possibly sooner.
We meet all the requirements so I’m really hoping to get in this trial just would like to know what’s being covered so I can save for the rest because we are OOP


#5

A Phase III Study to Compare Efficacy and Safety of AFOLIA vs. Gonal-f® in Infertile Women 35 to 42 Years of Age Undergoing in Vitro Fertilization (IVF) - Full Text View - ClinicalTrials.gov

That’s the link from the clinical trials govt site. I’m too young for it, but good luck to you ladies :slight_smile:


#6

I can’t believe I found a study for women over 40 lol very uncommon! You can’t have had more than 2 previous IVF’s. Good luck in your journey gigi3!


#7

More locations has been added to clinicaltrial.gov. California locations has not been added yet.


#8

Just noticed it was updated! I was hoping there would be one in my area and there is! Never attempted to get into any trial before so I have no idea what’s gonna happen lol
Tubal01 did you get one in your area?
Have your heard anything about what’s being covered in this trial?


#9

No, I’m in California they have not listed those locations yet. This might be a free trial, that’s what it looks like.


#10

I saw that one - good news - I’m in Canada and hoping it is open to everyone - will travel :slight_smile:


#11

Not sure what to think of this but I just talked to the coordinator at the clinic near me and she said they haven’t received the budget yet but that it looked like most everything will be covered but she wasn’t .100% sure yet BUT that she knew that the trial would cover up to 3 IVF attempts if the 1st 2 are unsuccessful, whatever that means. 3 IVFs covered?? Wow!!!


#12

The locations listed are the first run … starting in May. There will be a second group of locations, IF they do not get enough people through the first round. I spoke with Mike Floyd this week and he advised to get into the first trial centers and not wait for one to come to your area in August. From what my RE has shared, everything is included, three fresh chances for success. I am not sure about the frozen embryos that might happen… I believe I will be starting in late May or early June.

What is most exciting, is that Gonal F having competition now with Afolia may drive down med. prices in the future for IVF patients. :cheer:

I would make sure your pap and infectuous disease screenings are all up to date so you will be ready to go! I needed these completed for the last study I did.


#13

RLV,

I am lucky enough to have a participating clinic about 20 miles from me. I’m am praying very hard that I am able to get into this trial. I am almost 42 and running out of time. I never realized they had clinical trials like this until the last few months.
I have spoken with the clinical trial coordinator at the clinic near me and she said they didn’t have budget yet but that she thought it would cover , meds, visits and 3 IVF’s cycles. I’m just shocked and keep telling myself if it seems to good to be true, it usually is lol
So do you get the impression that most everything is covered?

I had all those test done with my 1st IVF last year its probly been almost a year, do you think I will need them again? If so, were should I go to get them?
What area are you in if you don’t mind me asking :slight_smile:


#14

Hi. I have been waiting for this study to start since November. I seem to have totally different information than all of you so I’m planning to contact the study coordinator at the clinic to double check my understanding. I was told only the medication is included in the study. I was also under the impression it was just a single cycle. They are not accepting participants yet but my study coordinator said she was hoping to get started the end of May. She couldn’t guarantee a start date. I’m frustrated because initially there was the thought it might have started mid last winter or early spring. The longer I’m waiting the more anxious I’m getting. It seems this exact study was already conducted once before with good results. If you google the name of the medicine you should find that study and results. I am hoping I am wrong and you are all right and it is 3 cycles and free. I’m really doubtful though. Our study coordinator knows how hard we are trying to get money together. My clinic is in PA.


#15

Spoke to my study person and apparently it is up to the clinic how much of the study is free. My clinic isn’t doing it for free but others might. Also I was incorrect and it is good for 3 cycles it looks. Unfortunately 3 cycles doesn’t help as much if you are still paying for the study though it does help. Trying to hang in there till the study starts and we can get all the details. Free would have her a dream come true! Lower priced is still good though.


#16

The coordinator at the clinic I’m hoping to get into was the one who told me that they didn’t have the budget yet but she knew it consisted of 3 IVF’s . She stated that she thought it covered meds and visits. I asked her if meds and visits included the actual “IVF” and she said that she couldnt be 100% sure yet but it looked that way.
I am still sceptical because it seems too good to be true, so I’m trying to be patient and wait it out. I’m assuming all clinics are different but she said they wouldn’t be recruiting till aroung July or August.
Good luck to you!!


#17

Has anyone gotten any additional information on this study?

I did send an email but didn’t get a response back.


#18

Just checking in…I don’t know how all you guys are doing but all this waiting is killing me lol


#19

I was told that they wouldn’t have any information on what is covered until July. This seems to keep getting delayed.


#20

I was told this week that they wouldn’t be screening people until end of July/early August. The study coordinator nurse at the clinic sent me a pre-screening form and it said the 1st IVF cycle was $2,000 and the 2nd and 3rd would be $1000 each, if needed. I never got an answer when I asked if the $2,000 included everything or if there were any other costs such as laboratory, anesthesia, other meds, etc. The cost if only $2,000 is fantastic but the live birth rate at the clinic is awful - 12% for women aged 38-40, which is half the national average. Brings up some major doubts. I was also told people that were already patents at the clinic would get priority and for $300 I could set up an initial consult appointment to get registered as a patient of the clinic.