Dear Readers,
I just read a news release from the big drug manufacturer Merck that they have been approved by the European Commission to market a new drug for IVF patients that will make their lives remarkably easier! It is a sustained release follicle stimulating hormone called Elonva, the first of it's kind! Whereas women undergoing IVF now have to have daily subcutaneous injections of FSH, with Elonva they will only have to have a subcutaneous injection ONCE a week. This is a significant improvement, thanks to the Organon division of Merck pharmaceuticals.
From what I have read in their press release, this new long-acting FSH lasts for 7 days. It has to be used with an antagonist so that doctors that already use antagonist protocols will have an easier time adapting to the new regimen. Those that use the long protocol will be less amenable to use it because they will have to get comfortable with two new meds. It will replace the first 7 days of injections required by currently available medications. Hopefully, the cost of medication will be equivalent or less, but for sure patients will appreciate the reduced number of injections! I can't wait for an FSH/LH equivalent for my mixed protocols. I hope the FDA approves it ASAP for U.S.A. use. Otherwise, I might have to take a lot of trips to Europe :-)
See the following link to get more information: http://bit.ly/cQpXn5
Here's hoping for a quick release for our patients in the United States!
Edward Ramirez, MD, FACOG
Executive Medical Director
Fertility & Gynecology Center
Monterey Bay IVF
I am currently pregnant following an IVF drug study using Elonva here in the US. This is phase III clinical trial- the final trial for this drug in the US. I am lucky to be pregnant. I have met many others who are on this protocol for the study and the egg response has been dismal and practically no women are getting any embryos to freeze. So, far, all have miscarried their pregnacies early (of those who even got pregnant) except for me. Im only 6 weeks along, though.
ReplyDeleteMost of the women I am meeting in this trial are NOT happy with this protocol- whether we got the study drug or the regular follistim. You have a 50/50 chance of getting the study drug and it is double placebo- so neither dr. nor patient knows who got which drug.
Just wanted to put in my two cents worth. If I had paid for this cycle, I would have felt ripped off. I had an excellent antral follicle count and FSH to start with. We were dealing with male factor infertility.
Thanks!
Thank you for the feedback. It will be interesting to see what the clinical trial results are once they are published. As yet, there is limited experience with this medication and I doubt that many clinics accept it right away. In some medications it takes time and experimentation to realize the best way to use the medication. Sometimes it is not the same protocols as the pharmaceautical company originally planned. We'll have to see, but your words are worth consideration for both patients and doctors alike.
ReplyDeleteYou are welcome- I hope my comments will help people. I do think maybe one reason the response has not been great is that it is an antagonist protocol with no lupron or birth control pills to start. They do not put your ovaries in a resting state before the IVF cycle. I guess that is standard for the antagonist protocol?
ReplyDeleteThey wait for your natural cycle to start and then on cd2 or 3 start stims. Most women have only stimmed a short time- 7 to 9 days. After 8 days, if your follicles have not developed as well as they like, they will give you open label follistim for as many days as needed until you have 3 follicles at 17mm. I stimmed 8 days and had one day of open label drug. I believe I got the study drug, as one peculiar thing some women have noticed is that the uterine lining comes on really strong. The first day of getting my study drug/placebo I felt a lot of ovarian twinges and discomfort. It was very strong. But after that first day, I felt nothing going on, and my follicle growth slowed down considerably toward the end of the week. My lining came on strong on stim day 3 at 15mm! Some other women had similar experiences and so we thought maybe we got the study drug.
There were a few women on a study IVF board I follow, who actually preferred this protocol to others they have tried, as although they did not get a good response as far as quantity, the quality of their eggs were much better- zero to little fragmentation and perfect grade embryos. I only got two embryos that fertilized well and made it to transfer. I had none to freeze and so far, about 90% of women on the board are ending up with only two embryos and none to freeze, even though some have gotten really good retrieval numbers.
I, too, am interested in seeing the study results once they are published. One researcher on the board (I think perhaps an RE or study coordinator) is saying their clinic is getting a 25% pregnancy rate on this trial.
Hope this helps and thank you for writing this blog with the desire to help and educate women.
Is the IVF board you refer to public? If so can you please post the url
ReplyDeleteI have premature menopause! am 34 yrs old is this safe for me or efective?
ReplyDeleteThis medication is not for premature menopause and will not work for you. Premature menopause is a condition where the ovaries stop functioning. Your body naturally produces FSH (the hormone within this drug) that is usually the hormone that stimulates ovulation. But your ovaries no longer respond to this hormone. Therefore, taking this med or any other fertility medication will not work for you. There is no way to stimulate the ovaries once they have shut down.
ReplyDeleteHi! I'm a poor responder who was on 2 antagonist cycles with the highest stim meds possible... But only one egg retrieved each time, with no embryo for transfer. High FSH, low AMH...
ReplyDeleteRE suggested using Elonva, but just wondering is it doing more harm than good? Feels like I'm pushing the ovaries which doesn't work well with high dosage...
The only difference between Elnova and what you used in the past is that it is a long-acting FSH. One injection is good for 7 days, whereas with current injections, you have to take it every day. So, it is not doing any new in terms of stimulating the ovaries.
DeleteUnfortunately, your ovaries have reached the point where they do not stimulate well, or as I tell my patients, "they will only stimulate as well as they can." So, no matter what dosage you used, even if it is the lowest dosage, you probably will only get 1-3 follicles. But keep in mind another point I make with my low responder patients, "it only takes one good embryo to get pregnant".
Good Luck
I’m 42 years of age and trying to have my second child since June 2012. We have now had a total of four embryos (good-quality blastocysts) transferred from two IVF stimulation cycles (Gonal F 225 – Cetrotide 250). None of the embryos have implanted.
ReplyDeleteIn May 2012, my Anti-Mullerian ormone (AMH) level was 27.7 pmol/L. A laparoscopy and hysteroscopy diagnosed that I had a Grade 1 endometriosis on posterior uterus in June 2012 but that I was able to start IVF stimulation without treatment.
Would you recommend to start another GnRH Antagonist Cycle with a lower dose (~ 180 Gonal F) after six weeks with the oral contraceptive pill or having a third cycle using a new drug called Elonva in an attempt to improve the quality of the eggs and egg numbers? Does Elonva exposed women to less LH?
Again, thanks so much!!!