Shortage of Pregnyl

By now, most of you should have noticed that Pregnyl has been out of stock for a couple of months. Well, the bad news is, that it may only be available again middle of 2009. Donmed has problems in raw material supply. Purgonin is long time not available, as is APL. Serono has replaced their Profasi with the drug called Ovidrel.

The latter is what I'm going to discuss here.
But first some Geek talk:
The substance in Pregnyl and Profasi is known as Human Chorionic Gonadotrophin. It is derived from urine in its natural form. It's a peptide hormone, produced from placental tissue during pregancy. It has LH effect and you all know from a previous string how LH produces testosterone. HCG has two sub-units. An alpha unit of 89 aminoacids, the Beta-unit of 148 aminoacids. Now, the interesting part is that the 89 aminoacid alpha unit is also commenly shared in LH, FSH and TSH. Keep note of this fact!

OK, now enters the interesting drug Ovidrel...
Ovidrel is HCG alpha 250mcg's per ampule. It's dose per mcg total equates to 6500IU's of HCG, but in effecacy equals Pregnyl 10 000 IU's! Yeah, you read it right! One ampule Ovidrel contains the effecacy of 10 000 IU's of original Pregnyl. Why was it developed and how? It was developed by recombinant DNA processes, similar to that of Human Growth Hormone production and the why is just as interesting. It was found that the Beta sub-unit has a lesser effect on the testii than the alpha sub-unit and that the alpha sub-unit in fact was the component in HCG that does the main work on the testii.

Now, let's go back to the fact I asked you to take note of. Remember I mentioned that LH, FSH and TSH has the same alpha sub-unit? So, by using Ovidrel, you will have a "TRIPPLE" effect. Firstly, your LH effect will increase testosterone production, secondly the FSH effect will have testicular tissue enhancement and Sertoli cell stimulation leading to higher sperm production, and thirdly the TSH effect producing more T4 to convert to T3. Pregnyl consists basically of the Beta sub-unit. That's why we test B-HCG in urine for OTC pregnancy tests. So, Pregnyl only has a LH effect.

Ovidrel is very pure in consistency - it is pharmaceutically derived in a lab. Pregnyl comes from a urinary source, even though it is pharmaceutically standardised.

Ovidrel retails wholesale for about R260 excluding VAT, similar to Pregnyl.

I am receiving some studies and literature from Serono tomorrow - will have a look at it and if there is more interesting stuff, I will bring it to the Board.

sounds like a winner,can u split dosage it like u would pregnyl 5000iu? like take .3ml every 5 days or must it be administered all at once?

Thank you for the interesting read, Doc.

Quality stuff Doc.

Doc -thank you for that article - I have tried to find studies on this product as it relates to men (effects and side effect)and can only find articles on effects on women.I would very much apreciate any info you could send my way.

Conan, the product is registered for hypogonadism treatment in men so far only in Europe. Typically not in SA yet... When I spoke to the product manager yesterday, she was very helpful in supplying me with the data. She promised to send me three different studies used in men, for me to have a look at. She posted these to me this morning. I will read through all the Geek stuff and supply the applicable info to you.

Hopefully these studies will also shed some light on the biochemistry of the product, otherwise I will bug them until I get that from them too.
All in time.... unfortuanetely, African time.

Good work doc ,,,

Another alternative to look at is Menotropin (HMG) Some of the guys in europe have been using it

OMG,, got this off the Ovidre website


"The Ovidrel® PreFilled Syringe is manufactured to the highest standards of purity using recombinant human DNA technology. Ovidrel® PreFilled Syringe is the only hCG available for subcutaneous (just under the skin) injection in the United States. Other hCG products available in the U.S. are extracted from human urine and may require deeper, intramuscular injections."

Lol,,, I guess than means they ran of Urine to make Pregnyl

About the Ovidrel. Here's some more info. It does NOT need to be cold chain transported, but should be kept under 25 degrees C upto reconstitution. After reconstitution, it should be kept in the fridge at between 2-8 degrees. I asked for the paper on its biochemistry and pharmacodynamics - it was also sent off this morning.

Just to re-iterate something:
the 250mcg HCG alpha by Dalton Molecular weight equals ± 6500IU's of HCG by weight, BUT by effecacy it equals 10 000 IU's of Pregnyl.

As for the Menotropin, it is available in SA in the product called Menupren(or Menopren - can't remember !). It is a mixture of menotropin(HMG), FSH and LH. It is f%^&$#ng expensive. Ten 1 ml amps will set you back R1580 excl VAT and that is Medical Wholesale price !

So, I guess the next question would be ...... How do we use the Ovidrel to get the desired dose of Pregnyl? Basically, if I want 500iu's of Pregnyl, what whould that measure up to in Ovidrel?

I have ordered 2 units today - my wholesaler didn't even list the product yet. They will source it for me in the next week. I will work this out for you and advise how to get to , say a 500IU dose.

The Menotropin product is called Menopur, produced by Ferring. The dosage of the menotropin in the syringe corresponce to the activity of 75IU's of FSH and 75IU's of LH. This means that if you inject one ampule of Menopur it would be the same as injecting 75IU's of FSH and LH each.

The dose of the Menopur for men for hypogonadism is one ampule every 2'nd day for 90-120 days. If your sperm volume stays less than 1,5ml, you still need to add in 2500IU's HCG twice a week ! Most of you will say "but I'm not worried about my sperm volume" . If so, you're missing the point. This is the simplist parameter by how you evaluate the effectivity of your PCT ! If your nuts don't get bigger and your ejaculatory volume does not noticeably increase, your PCT is ineffective.

Bottom line: I won't consider menotropin as a good choice... Ever wondered what the HMG stands for ? Human MENOPAUSAL gonadotrophin.

Hi Doc. Just pircked up my Ovidrel and it comes only with 1ml sterile water. I was planning on taking 1500iu's Pregnyl. So it means I have to devide 1ml into 6 because Ovidrel is 10000iu's. So i was thinking to use a insulin needle. My second q is must it be injected intra muscular or subcutaneous? In the leaflet it say under the skin so i'm thinking subcutaneous.

Vega, see if you can get the small multi-dose vials like the water constitute of Kefei, for instance. Reconstitute your Ovidrel into this little vial and mix in another 1ml sterile water(or use the unit of water of Kefei with only 1ml drawn out.I reconstitute Kefei in anyway with only 1ml water solution.) Now you have 6500IU's of Ovidrel(equal to 10 000 IU's Pregnyl) in 2mls solution, which, from now on you keep in the fridge at 2-8 degrees C. This now means that every 0,1ml of this solution will contain an effective dose of equal to 500IU's of Pregnyl. So, if you want to inject, say 1500 IU's effective dose of Pregnyl, you then draw up to the 30IU mark on the MicroFine insulin needle. This will be equal to 0,3mls or effectively 1500IU's of Pregnyl.
Neat, huh ??

I have ordered 2 units of Ovidrel and will have it hopefully somewhere this week. Will inspect it then.
I can only see the above method as a solution to the problem of the pre-filled syringe of the Ovidrel. See, Ovidrel was designed for women to be administered only once during their menstrual cycle. The company did not cater for the likes of us b/builders !
Ja, you will have to inject sub-cutaneously, similar fashion to that of insulin.

Price is not everything ,,,, do you think menotropin would be better


b]Doctari wrote:[/b]

About the Ovidrel. Here's some more info. It does NOT need to be cold chain transported, but should be kept under 25 degrees C upto reconstitution. After reconstitution, it should be kept in the fridge at between 2-8 degrees. I asked for the paper on its biochemistry and pharmacodynamics - it was also sent off this morning.

Just to re-iterate something:
the 250mcg HCG alpha by Dalton Molecular weight equals ± 6500IU's of HCG by weight, BUT by effecacy it equals 10 000 IU's of Pregnyl.

As for the Menotropin, it is available in SA in the product called Menupren(or Menopren - can't remember !). It is a mixture of menotropin(HMG), FSH and LH. It is f%^&$#ng expensive. Ten 1 ml amps will set you back R1580 excl VAT and that is Medical Wholesale price !

PricePRisc

batman, I don't think so.

cool,, we'll wait in anticipation to hear how the Ovidrel works..

I don't think the 5000iu pregnyl is much of a problem to get at the Moment though,, only 1500iu,,, or has the 5000iu run out as well?

Brother, all is out of stock! I even had my wholesalers check their fridges for missed stock.... Nope, not even there. Went through all the litrature on Ovidrel today - interesting...

Glad I have a couple of boxes put aside in my fridge for myself

Doc please will you check the length of time you can keep Orvidrel once mixed in the fridge-I've got a funny feeling that because its synthetic (much like HGH)the life will be a hell of a lot shorter once reconstituted .
Thanks

C, I couldn't find anything in the literature on that. I'm speculating here, but I think it will be a bit more stable than HGH, as the latter has 191+ amino acid chain, where as Ovidrel has 91 length chain. I'm going to reconstitute an ampule for myself, as well as my brother, and see how it works. Remember the product was designed for women, who need 5000 - 10 000IU shots at a time to induce ovulation. The studies I have in men uses doses of 1500 - 3500IU's twice to 3 times a week, but they do not comment on how it was "mechanically" administered.

Can't say at this stage. Went through all the litrature - it seems to be more stable and bio-available than Pregnyl. Pregnyl for instance needs to have continuous cold chain, even before reconstitution. Ovidrel only after reconstitution. So, let's see....

Tell you what I will do. I will contact Serono again and post this question of smaller , multiple dosing to them and see what they say...

OK, this is what I have found out directly from their product manager, after he consulted with the biochemists who developed the drug. Ovidrel does not need to be cold storaged until reconstitution. In fact, it does not even have to be kept in the fridge after reconstitution, as it is stable under 25 degrees C for upto 28 days. Cold storage will lenghten this period even more. Thus, here we have a perfect product to use in any dosage your heart desires, without having to hassle too much about cold storage and it will stay biochemically active for 28 days minimum.

If it is administered intra-venously, the half life is 4 hours. Sub-cutaneously it is 30 hours. Intra-muscularly some where inbetween.
Thus, dosage regimes with Ovidrel can be every 2 1/2 - 3 days. In fact, ALL the studies I have where it was used, it was used twice a week at dosages ranging from 1500IU's to 3500IU's at a time. Remember these are MEDICAL studies in male hypogonadism and I have about 10 different studies, all using the same dosage regime with IU's administered twice weekly. In only one study, it was used three times per week.
Now, I ask again : what's up with this low dose daily administering in PCT? Especially if all the medical studies done specifically for men with "under-performing" testii use higher dose, twice weekly regimes. Can the whole medical community be that wrong, and the body builder community that right ?????

Doc I have followed this particular HRT therapists protocol ( and there are many others(therapists) in the states who agree with this protocol )
So here goes...
'I advise my AAS patients to use small amounts of HCG (250IU to 500IU) two days each week, right from the beginning of the cycle. This serves to maintain testicular form and function. It makes more sense to me to keep the horse in the barn, so to speak, then to have to chase it across three counties later on. I am also a big fan of maintaining estrogen within physiological ranges. Both therapies have been shown to hasten recovery.

Any more than 500IU of HCG per day causes too much aromatase activity. Some feel aromatase is actually toxic to the Leydig cells of the testes. You are then inducing primary hypogonadism (which is permanent) while treating steroid-induced secondary (hypogonadotrophic) hypogonadism (which is temporary--hopefully).

If 250IU or 500IU on two days each week isn’t enough to stave off testicular atrophy, then I recommend using it more days each week (as opposed to taking larger doses). In fact, I wouldn’t mind having a guy use 250IU per day ALL THROUGH the cycle. Those that have tell me they thus avoid that edgy, burned-out feeling they usually get. They also say they simply feel better each day. Subjective reports, to be sure, but they are hard not to appreciate. Especially when HCG is so inexpensive.

The testes are then ready, willing and able to again produce testosterone at the end of the cycle. LH levels rise fairly rapidly, but endogenous testosterone production is limited by lack of use. I also want to make sure a SERM, such as Clomid or Nolvadex, is at effective serum dosage (around 100mg QD for Clomid, 20-40mg QD for Nolvadex) when serum androgen levels drop to a concentration roughly equal to 200mg of testosterone per week. That is when androgenic inhibition at the HP no longer dominates over estrogenic antagonism with respect to inducing LH production. Of course, if the fellow has been doing Clomid or Nolvadex all along the way (and I now prefer Nolvadex over Clomid, due to the possibility of negative sides from the Clomid), he is all set to simply continue it at the end (no need to switch from one to the other). BTW, I see no evidence of any benefit in using BOTH SERM’s at the same time. I used to think a couple of weeks of the SERM was enough; now I like to see an entire month after the last shot of AAS (and migration of long to short esters as the cycle matures). Tapering the SERM is probably a good idea during the last week, as well.

I want my patients to stop taking HCG within a week after the end of the cycle. The testosterone production it induces will further inhibit recovery, as will using Androgel, or any other testosterone preparation, while in recovery. There is no escaping this, as there is no such thing as a “bridge”. Just because you are not inhibiting the HPTA for the entire 24 hours does not mean you are not suppressing it at all. IOW, you can’t “fool” the body—it is smarter than you are.

I like Arimidex during the cycle (in fact, consider use of an AI while taking aromatisables a necessity) but it ABSOLUTELY should not be used post cycle (even though it has been shown to increase LH production) because the risk of driving estrogen too low, and therefore further damaging an already compromised Lipid Profile, is too great (this also drives libido back into the ground—and we don’t want that, do we?).

All this is meant to get my guys through recovery as fast as possible (the real goal, yes?). So far, all of them who have tried it have reported they are recovering faster than when they have tried other protocols'

Doc I hope this explains my point of view .
Doc thank you so much for that info on Ovidrel I do believe this new info makes the product more economical than pregnyl

Hi Doc and those using Ovidrel,

It's been a while since your last post about this HCG alternative to Pregnyl - can anyone comment on the results? Is it "better" then Pregnyl?

Would really like to hear about your experience using Ovidrel.

Thanks