Hey everyone here’s a little update as to where we are!
Monday, December 3, 2018
Matt and I went into our doctor’s office to sign all the legal consent paperwork regarding the This is a Randomized, double-blind, placebo-controlled, parallel group multicenter trial investigating the efficacy and safety of FE 999049 for women ages 18-34.
RITA Study Which means Recombinant FSH Investigation in the Treatment of Infertility with ART ( Assisted reproductive technology)
This study will have at least 550 Women in the United States participating, the study covers one ovarian stimulation cycle with a transfer of one fertilized egg.
In this research study, you will be randomly assigned to receive either FE 999049 (active substance) or placebo (inactive substance). This medication is available and approved in 37 countries and the FDA has finally allowed the US to run this study trial. As I mentioned before this study is being 100% paid by the sponsor ( such a blessing)
We will begin stimulation once I start my December period which we are looking at that being the end of December. Once stimulation begins I will receive all the medication needed for the first 5 days of the study, a diary to keep all my notes. On the 5th day, I will return to the study office return all my used medication, turn in my diary. I will remain on the medication or placebo for up to 8 days, at this time I will return to the study office return all used medication, diary and at this time if the Doctors see there has been no change in my hormone levels and or I show no follicle growth I will be taken off the medication and will be removed out of the study, once this is done the sponsor will begin a real IVF cycle with active medication.
For each visit to the doctors, I will not be able to see the ultrasound screen, know my blood work results and If I ask how things are all they can tell me is good!
This is because they don’t want emotions and psyche to negatively or positively affect the results. The study has presented documentation the shows some people responded to the placebo with positive results. Just goes to show how much your emotions can affect everything in your body.
Along with the study consent forms we also had to sign off that if pregnancy is achieved and goes to term we give the study permission to call us 1 week up to a year at any time to check on the health of the baby.
Wednesday, December 5, 2018
I returned to the doctor to have my blood work, Ultrasound and a physical done! We should receive the results of the blood sometime this week.
We are very excited to begin this study! As always thank you ALL for the support and love every single day!