AHHH!!! All the uncertainty about the return of the MS trial is killing me!

Ok, so that was a little dramatic but it is really stressful  I really wanted to cycle in June or July of 2009 but now I'm worried.  Do you guys think the trial will get another extention?  If so, how long do you think it might take to return?  I would just go ahead and bump up my ttc time but I don't plan on weaning my son until he turns one in the beginning of April.  I know it doesn't seem like a huge deal to some but I nursed ds1 for almost 2 years.  I didn't plan to nurse past a year this time regardless but still...it just doesn't feel right for me.

 How is everyone else feeling?  It just seems that the uncertainty about the trial dates, times and return is so much added pressure. 

Anyway, I know we all have many other things on our minds I was just wondering where you ladies were at in your thinking...

Even if the FDA does not approve "Microsort" they will still be able to offer the service off-brand just like other "sperm spinning" people. Obviously, the approval would do wonders for them as far as marketing is concerned but the service will continue under some name.

Yeah, I imagine that would add some stress—having to rejigger your schedule like that. Does this just apply to GIVF right now? If so, would you consider HRC, or is that too far? Hope this gets cleared up soon for you!

I'm not sure if it's just GIVF or not.  I'd definitely consider HRC.  I think my husband would prefer GIVF just because if we had to drive we could...even though it would take 10-11hrs.  I wish I could just sign up now for June and start mentally planning.  I guess I just need to come to terms with the fact that nothing in this whole process is guaranteed.  Thanks for your thoughtfulness. 

 I just welcomed you in an earlier thread .  I think our little guys are probably only a few months a part.  I know you said that you just submitted your paperwork for summer/early fall.  Did anyone there say anything about availability during that time?  We might be cycling together...who knows .

 Thanks again and welcome~

Im worried.....I plan to try and cycle at either of those clinics OR will use a local clinic and have the sperm "shipped" and frozen...yet Ive heard its not good on the sperm.....its all going to depend on our cash flow.  Im terrified that it wont be available next August or October when I plan to try.

I can't imagine that MS won't get another extension. I think it's really just a formality. They already got one extension, and nothing has changed that would make the FDA turn down another one. It's just that the extension was only for a year and the year ends in April, so they have to jump through the beaurocratic hoop again. My guess is that there really won't be any down time. That's only my guess, but I think someone posted recently that they talked to Kelley at HRC and she said about the same thing.

I'm not sure that MS could continue to offer their services if FDA approval was denied. I think the FDA trial has more to do with safety than with the effectiveness of the sperm sorting. If there was a safety problem that let to rejection by the FDA, I would hope they would have to stop. BUT, in twelve years and over 1000 births, there is absolutely no indication of any safety issue with MS. I would be stunned if they did not get FDA approval. It sounds like approval will likely come early next winter, so even if there is a bit of down time (which I really think is unlikely), approval isn't that far away. But I know how hard it is to wait and deal with the uncertainty about the trial. My failed MS/IUI was right when the trial closed, and I had to wait 10 months to try again (and succeed!)

Mieyonna -  

Hopefully it will come back quickly.  I guess the only thing we have to compare it to is the September 2008 extension.  It came about fairly quickly.  I wonder why HRC was allowed to continue and GIVF was not.  Do you know if that will happen again this time?  

I pray that everything will fall into place for you exactly as you hope.  I just know that God has picked another precious little man to complete your family. 

Mom2RJ -

Thank you for your reassuring post!  Your story definitely gives me hope.  I'm sure that 10 months felt like an eternity for you.  I thought the trial closed in September.  I had no idea it was before that. 

 The best thing for me to do is probably just make contact, submit my paperwork and see what they suggest from there.  It's a big step for me to actually come off these boards and REALLY get the ball rolling.  I waited almost 2 1/2 years between ds1 and ds2 to get pregnant again.  We really want our next child to be closer in age.  It seems crazy to be thinking about getting pregnant again when ds2 is only 8 1/2 months old.  Exciting but crazy .

 Thanks for your input.  You are always so informative and reassuring!

My entire concern is that I get pregnant BEFORE I turn 35.  I will be 34 in March of 09.  They say the health risks to the baby and the stats for IVF drop if you conceive after 35.  If they have a 10 month wait, I will be past my time frame and may end up having to try IVF/PGD and just PRAY I have enough boy embies to suffice.  I want to cry!...lol

Mom2RJ, it looks like you did better with the Clomid and Ovidrel.....When you say follicles, is that how many eggs they retrieved or how many they were able to fertilize?  And the purity sort.....is that where they test the sample of your DH sperm to see how many X or Y are there after the MS?  I think I have asked this before, but there is SO much terminalogy that Ive just not gotten it all 'down' yet.  It reminds me of having to learn "text talk" to even attempt to communicate with my daughter.  She walks by and says things like "OMG, DHAC mom" and I'm like H.U.H? lol. I got the OMG part but DHAC?  I should'nt have even asked....I got an eye roll and a "Dont have a Cow"...then she sticks that smirky little tongue out and runs cuz she knows my hand is reaching for her backside even as she turns...

Mom2RJ:

 BUT, in twelve years and over 1000 births, there is absolutely no indication of any safety issue with MS.

How do you know this?  When I spoke to Microsort they told me there HAD been serious birth defects from MS sperm (but nothing that they could point to as being 'statistically significant')... now I don't know what 'statistically significant' means to them.  And I also wonder if some birth defects don't make it into reporting b/c the pg is terminated b/c of a serious birth defect.  Is MS reporting ALL defects or just live birth defects?

 

I would think that in those studies they would have to see how many were IUI and just sorted sperm verses PGD with IVF and MS.  I would think there would be SOME birth defects to report with any pregnancy's.....MS just sorts the sperm, if the couple is not having an embryo made and checked for defects after using MS, then its entirely possible that the defects were naturally occuring...even with IVF/PGD, the "try" to put back the healthiest looking embryo, but if you are not specifically testing for defects then you still have a chance of something going wrong that would could have happened with a natural conception....yet it would be almost impossible to prove HOW the defect came about.....unless the defects are all identical in nature and may have been coming from the same clinic? 

The trial closed in September 2007 because they were about to reach the number of births allowed in the original trial. They got an FDA extension in April 2008 that apparently was for one year, so now they need another extension to continue beyond April 2009. HRC and GIVF both have to follow the same rules and both continued offering MS. The only difference is that GIVF stopped offering IUIs in October 2007 to devote their staff time to preparing the FDA approval documents. They will start IUIs again in January, which makes me think the paperwork is probably just about done. Stopping IUIs was a staffing decision at GIVF, not an FDA decision.

Yes, there have been serious birth defects in babies conceived using MS, just as you would find serious birth defects in any group of 1000 babies. For it to be statistically significant, there would have to be a particular birth defect seen in a larger percentage of MS babies than in the general population. This has not happened. I don't know if miscarriages and terminations related to birth defects are included in this reporting, but I doubt they are included in the birth defect stats for the general population either. The important thing is to show that there is no higher incidence of any birth defect that can be linked to the use of MS, and so far that looks very good.

Mieyonna:

Mom2RJ, it looks like you did better with the Clomid and Ovidrel.....When you say follicles, is that how many eggs they retrieved or how many they were able to fertilize?  And the purity sort.....is that where they test the sample of your DH sperm to see how many X or Y are there after the MS?

 

I did IUI, not IVF, so my eggs were not retrieved. I had three mature follicles and the sorted sperm was put directly into my uterus on the day I was ovulating and left to fertilize the eggs on their own. One of my three eggs became a baby. Yes, I did better with Clomid and Ovidrel. With my natural cycle I had one follicle, I'm not sure we got the IUI timing right, and I did not get pregnant.

Yes, the purity sort is where a small sample of the sorted sperm is tested to see the X and Y percentages. In our case it was 92.99% X, and we can assume that the entire sample was pretty close to the small sample they tested.

I know what you mean about learning the lingo. When I first came to this forum I had no idea what all these acronyms meant!

fairytaledreams:

I'm not sure if it's just GIVF or not.  I'd definitely consider HRC.  I think my husband would prefer GIVF just because if we had to drive we could...even though it would take 10-11hrs.  I wish I could just sign up now for June and start mentally planning.  I guess I just need to come to terms with the fact that nothing in this whole process is guaranteed.  Thanks for your thoughtfulness. 

 I just welcomed you in an earlier thread .  I think our little guys are probably only a few months a part.  I know you said that you just submitted your paperwork for summer/early fall.  Did anyone there say anything about availability during that time?  We might be cycling together...who knows .

 Thanks again and welcome~

I submitted my paperwork last week and haven't heard anything yet. I'll probably call soon. I don't want to move my cycle date up, so if there's a delay, I'll probably just wait it out. My guys are 21 months apart, and that's about as close as I want to go, with working full time and childcare expenses and the like. There's supposed to be some announcement today regarding MS/IUI, perhaps about an extension??, so maybe we'll both know something very soon. It's hard enough to finally make the decision to do this. To not know when is indeed frustrating. Best of luck to you!