Consultation re IVF - REFRAMING (Part 1)

Written by Arpee on September 23, 2008 – 11:51 pm -

We had our consult with DrH and she was very accomodating. She answered all our questions - I didn’t necessarily like all her responses, but it is good that she didn’t sugar coat it. She said that she would have discussed most of the topics anyway but appreciated the questions I sent in because it gave her an idea where we were coming from.

She said that she wished there were more couples who were more concerned on what would be done to their embryo.  She just gave me some more additional things to dig more on too…

Anyway, I wrote all that I could remember from our consult … yes I forgot the recorder… and writing it down resulted into a very long post, so I am broke it into 3 parts.

OUR INFERTILITY FACTORS
The factors we are facing are Advanced maternal age, PCOS/Anovulation and Low sperm morphology:
- PCOS/Anovulation can be “tricked” by controlled ovarian hyperstimulation (COH).
- Low sperm morphology effect would be minimized with IVF.
- So, the only factor that we cannot do anything about is the advanced maternal age - that determines the egg quality. (I got the usual talk about “women are born with all the eggs for their whole lifetime. As the woman ages, the quality of the eggs “deteriorate”.” In essence, my eggs are old… my raw materials have deteriorated. :(

Re my 3.5 FSH - DrH said that what it means is that for a 40-year old woman, that was good. However, it still does not compare to a 25-year old woman’s eggs who tests as 3.5 FSH. My eggs are still 15 years older!


WHAT OUR IVF WOULD LOOK LIKE
Since I am a good responder to the gonadotropin, DrH expects to be able to harvest a lot of eggs if I undergo COH in preparation for IVF.  However, she said that fertilization and viability of embryos from eggs of someone my age may not be very good, so just fertilizing a few eggs will not make sense and that the procedure will not be worth it. She also recommends to transfer back 3-4 embryos since the implantation of embryos for someone of my age may not be very good as well. (So that means the “fate” of embryos that are not transferred is a real key question.)

As for typical reasons for IVF cancellation, DrH mentioned 3:
- low stimulation
- overstimulation (typically for younger women)
- ovulated early (or early LH surge)

What to expect with Lupron?
- Before starting, ultrasound to make sure there are no cysts
- Start Lupron. Attend IVF Orientation
- Expect period
- Baseline ultrasound

DrH said that the Follistim dosage she would use for IVF would be at the same level as our 1st Follistim stimulation (that was cancelled) which showed I was a good responder. So instead of the $3K medicine cost estimate, she thinks I would only be using $1.5K worth of meds.

Progesterone is going to be intramuscular (IM) injection…on the butt? on the thigh???. (I was hoping it was just suppository even if it was a bit messier.) Uuuggghhh…

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How to Maximize the Use of Follistim

Written by Arpee on August 19, 2008 – 5:38 pm -

Follistim is an expensive medicine - it costs about $0.78 to $1.3 per IU. So it is very important that as much as possible everything is used, nothing is wasted and any Follistim leftover maximized for use. Here are some things to keep in mind in order to maximize the use of this precious drug.

1. Understand that your RE will make an assumption on how much you will probably consume based on your factors (age, reproductive health and history, etc) and thus what you will be given a Follistim amount that will be just an estimate. How much Follistim you really need is not known until you actually go through your cycle since your daily dosage will be adjusted based on your own response. Be prepared to buy more or store leftovers.

In my case where I am of advanced maternal age and have been annovolating for more than a decade, I was adviced to order a 900IU cartridge and a 300IU cartridge. (I paid about $900 for those.)

My RE expected me to produce only a few follicles at a “high” dosage due to my background. She did not expect my actual prolific reaction! I ended up using 650 IU for that first cycle so I actually punched through the 2 cartridges.

2. Know the official statement from the manufacturer by heart! You will need this.

Follistim Pen® with the Follistim® AQ Cartridge may be stored by the patient at 2–8°C (36–46°F) until the expiration date, or at 25°C (77°F) for 3 months or until expiration date, whichever occurs first. Do not freeze.

Once the rubber inlay of the Follistim® AQ Cartridge has been pierced by a needle, the product can only be stored for a maximum of 28 days at 2–25°C (36–77°F).

Protect from light. Do not freeze.

3. Know your own cycle day count by heart as well. Be ready to make some counting or calculations. Do not assume that RE/staff is on top of all the details of your case.

My first Follistim cycle was canceled because of my prolific response to the dosage and had all the signs of an impending OHSS. So my RE told me to just refrigerate the Follistim leftover.

When I was ready to do my second cycle 34 days later, my RE prescribed a lower dosage and told me to use the Follistim leftover. I used it for 3 days and in my first monitor, it seemed like I was having a normal response. On my 5th day of stimulation, I was reminded of the above Follistim literature statements from reading it before the 1st cycle.

At first, I was thinking that it must still be okay since my RE told me to use the Follistim leftover. I assumed that my RE would not actually tell me something that is detrimental to my case. I assumed that my RE was on with all the details of my case and thus, if the Follistim leftover was already expired, that my RE or the staff would let me know.

(I looked at my RE’s clinic stats in SART and they have 675 IVF cases in 2006, roughly 2 cases per calendar day. I suppose this is why they could not (or do not?) go to that level of detail (unless called upon to do so). Meanwhile, if you want more attention to details you might see it on smaller clinics. On this other hand though, I am thinking that you will run into the concern of “not having a lot of experience”. I guess you choose your “poison” - now that does not sound good.

Anyhow for me, I would rather have the attention risk than the experience risk. My thinking is that I can play a part to minimize the attention risk by being an informed patient whereas, I cannot do anything about my RE’s experience! My best choice though is if both are low in a particular clinic.)

4. Ask your RE questions. Call them if you must! There are no stupid questions (only stupid answers!). And… you are paying them good money, you have the right to ask questions.

I could not stay put though. I did not have peace. So I called the next day and asked about it. Long story short, I should not have used the Follistim leftover and I should use a new cartridge (which they provided free as promised previously). So, I started a new cartridge on my 6th day of stimulation.

5. Follow the manufacturer’s instructions on storage and usage - intact or pierced. In my “own” words since I am graph-and-table person (warning!), this table should make it even clearer:

Cartridge Rubber Inlay Storage Temperature Usable Until
New 2-8 C (36-46 F) Expiration Date (on cartridge)
New 25 C ( 77 F) 3 months or 90 days
Pierced 2-25 C (36-77 F) 28 days

(If you just want the numbers (follicle sizes) go to the Follistim Response page.)

In my case, having used expired Follistim for 5 days still seemed to have worked as shown by my follicle sizes graphically shown below (I warned you!).

Follistim Cycle #2 Response

I don’t know if the expired Follistim was really still working with its full potency or or if its potency has already weakened. I don’t know if the later new Follistim compensated the effects. I really don’t know but somehow it “worked” for me in growing these follicles.

I read from other ladies in one of the forum who also stimulated fine and some even got pregnant. That is not to say though that you should take the chance on expired Follistim!

One lady wrote in one of the forum something like, why try to skimp on $150-900 when your IVF costs thousands of dollars? Really true for IVF (maybe not for IUI though because that “skimped amount” could easily be 5-50% of the overall IUI cost). Too small a price when you consider the cost of the overall process. For a procedure as expensive as IVF, you would like to have all the optimal conditions in your cycle - and that includes “fresh, unexpired” medicines. I think this is what they describe as “looking at the forest instead of just staring at a tree”.

Also, I surfed the internet for “what happens if expired follistim is used” and some variations of that phrase - didn’t see anything (at least on the 1st page of the Google search results). One lady in another forum wrote that after 28 days of the rubber inlay is pierced, its potency is affected. Could not find her source though.

Meanwhile, I just really hope that there is no effect to the quality of my already “mature” eggs! No X-mens, please God…

I do wonder though why 28 days after the cartridge’s rubber inlay is pierced? Do they have empirical data on its impact to potency and other effects?.

It’s just very coincidental that the typical cycle is 28 days as well. As if the drug is not intentionally designed (formulated) to reach the next cycle - so that we buy another set? Conspiracy theory starting…but oh, well, that is another topic.

(NOTE TO SELF: Contact Organon V at 1-800-241-8812 Monday through Friday 8:00 a.m.- 5:00 p.m. EST. I will update this as I get more info.)

6. For intact (unpierced) Follistim cartridges that you are not going to use anymore for some reason - maybe you already got pregnant (good for you!), past the 1st trimester, on a TTC break or have closed your TTC book - there are a couple of things that you can do with them:

  • Sell it over the internet. I am aware of at least 1 website.
  • Advertise it in the internet - your blog or related forum. You can sell it or give it away.
  • Donate it to your RE’s clinic. That way, you can help others too.

Make sure you stored it properly!

I guess a lot of these are common sense but we can as easily naively trust our health providers and unwittingly think that all their orders are flawless. So, I think I cannot over-emphasize all of these! Also common sense as they are, the principles behind most of them can also be applied to whatever medicine you are prescribed.

Methinks there is no substitute to being an informed patient.

Meanwhile, do you have any other tips on what to do to maximize the use of the precious Follistim?

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10 Things About Follistim

Written by Arpee on August 18, 2008 – 5:34 pm -

I noticed that almost half of my blog visitors are looking for information regarding Follistim. So I figured it may be helpful to some that I put this together based on what I learned about it, what to expect, what Follistim dosages are, etc. So here goes…

Follistim’s generic name is follitropin beta.

1. Follistim is a recombinant follicle stimulating hormone (rFSH) versus the human menopausal gonadotropin (hMG) such as Humegon, Pergonal, Repronex and Menopur which are extracted from the urine of menopausal women.

I think the FSH term is self-explanatory, but as for the term “recombinant”? I am not a scientist but what I picked up is that it is a genetic engineering process that uses Chinese hamster ovary (CHO) cells in the manufacturing process. I am sure it is a controlled manufacturing process, but just the thought of injecting myself with something “mixed” with non-human feels creepy.

I guess we do choose our own poison - non-human derivative or human menopausal urine? And no, I am not making these up … see these sources. (a) (b) (c).

Of course, Organon’s website indirectly states “mammalian” host cells vs directly stating Chinese hamster ovary cells! I suppose they don’t want to freak us out!

2. Follistim is prescribed to women with ovulation problems. Typically, women who are clomid-resistant or have PCOS use Follistim. (I have read about other women having protocols that includes clomid and Follistim, though.)

Follistim is also used for ovarian stimulation in preparation for fertilization - usually using assisted reproductive technologies (ART) such as intra-uterine insemination (IUI) or in-vitro fertilization (IVF).

3. Follistim is what it is called in the US. The rest of the world calls it Puregon. They are made by Organon, a Schering Plough company.

Other fertility drugs that are used for similar results are:
- Gonal F (follitropin alfa, rFSH) from Serono
- Bravelle from Ferring (urofollitropin, highly-purified human-derived FSH or hFSH)

4. Follistim is usually used together with human chorionic gonadotropin (hCG such as Ovidrel or Pregnyl) to trigger ovulation.

Follistim is also usually used with an gonadotropin releasing hormone (GnRH) agonist and/or antagonist for IVF protocols. GnRH agonist such as Lupron blocks the production of FSH and LH, and is administered 10-20 days in the previous cycle. GnRH antagonist such as Ganirilex/Antagon or Cetrotide blocks the effect of GnRH, and is administered on the later part of the stimulation cycle. (a)

5. Follistim dosages that you will be prescribed is an ESTIMATE and will latter be dependent on the individual response.
Your Reproductive Endocrinologist or Fertililty Specialist has some baseline dosages in mind based on your individual case and thus will estimate how much you will be asked to order from the pharmacy. The protocol is started on between cycle day 3 (CD3) to CD5.

6. Follistim requires close response monitoring by sonogram and Estradiol blood test every 2-3 days.
Sonogram will show the endometrium lining thickness and the the follicle count and size. A gradual increase is desired from CD3 to CD14. (In my case, my RE wanted to see endometrium lining thickness greater than 9.5mm and mature follicle (size>18mm) count of 3 to 5 follicles before we trigger on the CD13-14.)

Blood work is needed to read the Estradiol (E2) levels as well. As a rule of thumb, it is said that for every mature follicle, expect 200pc/ml. (In my case, the desired level was 1500 pc/ml.) Levels greater than 3000 pc/ml are usually associated with Ovarian Hyper Stimulation Syndrome (OHSS).

See a sample of Follistim response data vs dosages here.

Throughout the protocol, the dosage may be adjusted or “titrated” based on your response to the Follistim. For some, a cycle’s dosage may be too low or was increased too late that the right size and number of follicles is not produced. For some, a cycle’s dosage may be too much or was decreased too late that results to Ovarian Hyper Stimulation Syndrome (OHSS). If the baseline or adjusted dosage works, well and good. Do not be surprised though if it does not work and you will need another Follistim cycle.

Just a note though that there is anecdotal information that one patient’s response could vary from cycle to cycle as well.

7. Follistim is expensive … but DesignRx can give you a big discount.

8. Follistim has an expiration - 28 days from piercing or 3 months at room temp or until expiration date when refrigerated.
How to maximize the use of your precious follistim? Can you use expired follistim? See tomorrow’s post.

9. Follistim has been in use for more than a decade now.
It was first introduced in 1995 in Europe.
It was introduced in 1996 in the US but the Follistim® AQ Cartridge was FDA approved only in 2004.
It was introduced in 2005 only in Japan.

10. Follistim is expected to become cheaper by 2015.
This is when Organon’s Follistim comes off patent. Expect the influx of generic manufacturers to lower the price by then!

Anything of key significance I missed, fellow Follistim-users?

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Where Are You Buying Your Follistim?

Written by Arpee on July 8, 2008 – 11:48 am -

Last month, I had my first cycle of Follistim. The Texas Fertility Clinic had a couple of brochures from different pharmacies where I could possibly get them from. One of the staff members though mentioned that I could get it at the lowest price at a certain pharmacy. Read more »

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CD25: Ultrasound 15 Days Post-Follistim

Written by Arpee on June 26, 2008 – 7:38 pm -

Today is the day to get my ultrasound done to see if the birth control pills have decreased the follicles that were stimulated by Follistim. From here, we will know how and when to proceed.

Well, here is the ultrasound image of the same left ovary I’ve been showing previously:
CD25 ultrasound left ovary follicles
Read more »

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CD6: Follistim Day 4

Written by Arpee on June 8, 2008 – 10:55 pm -

Beauregard HouseJune 7 is our 5th Anniversary and we are out of town - enjoying the sights and staying in a Bed and Breakfast inn!

I was about to give myself a 150 Follistim when Al remembered that he got an earlier call that I should reduce the dosage to 75, 75, 75 Follistim instead. Well, talk about timing. Almost had the double of that.

Since I was not able to talk to whoever called that in, not sure what triggered the Follistim dosage decrease. I suspect that the estradiol results had something to do with it. Read more »

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CD5: Follistim Day 3 Response (1st Ultrasound Monitor)

Written by Arpee on June 8, 2008 – 9:54 pm -

From St Davids Main, we drove to the Texas Fertility Center for an ultrasound monitor. I’m dreading it a bit since it will not be Dr Hansard who will be in. Instead, one of the male doctors, Dr Silverberg, will be the one on call/duty. I’m not really a fan of male doctors in obstetrics, gynecology or reproductive endocrinology but in this case, I have no choice, don’t I?

Guess who is in the clinic? Read more »

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CD5: Follistim Day 3 Response (1st Estradiol Monitor)

Written by Arpee on June 8, 2008 – 9:11 pm -

It’s a Saturday and the only lab open is St Davids Main at 32nd St, downtown Austin. That’s about 25 miles from home and we almost did not make it to the 8:00 am cut-off for the Estradiol blood draw. I was trying not to be affected despite the note that “failure to go to the correct lab could result in the cancellation of your cycle due to the delay in obtaining your results”. I pushed away thoughts such as - what if we were really late for the lab? that’s another month to wait again…that’s more than a $1000 wasted. Read more »

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