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by artofcode 3518 days ago
Also important to note that permanent infertility is quite a strong side effect

> Eight participants had not recovered to meet the criteria of return to fertility after 52 weeks in recovery phase, the last visit according to the study protocol. These participants were followed on a case by case basis until they regained normal sperm counts (n 5, up to 74 wk of recovery) or declined further follow-up (n 2). One volunteer did not recover within 4 years since his last injections.

http://press.endocrine.org/doi/pdf/10.1210/jc.2016-2141

5 comments

> One volunteer did not recover within 4 years since his last injections.

That's a really STEEP Price to Pay for an "experiment". Anyone know how much the participants were compensated for taking part in the study? No amount of money would make me do something like this. But that's just me.

To answer you question, I do not know what they were compensated. But I suppose if you already had the amount of children you wanted and were considering the ole snip snip, this might have been a considerable option. Maybe it's what they wanted? I do agree though that if this were a young man, I sincerely hope they made some frozen samples before committing to this study.
There's also the risk that the drug is not as efficient as expected, and you end up with an unwanted pregnancy, so participating in this trial is never a no-brainer.
Presumably they were strongly advised to use a second method of birth control.
I looked up the study, and it seems that participants were not allowed to use a second method of birth control:

"Couples enrolled in the efficacy phase were asked to rely only on these injections for contraception."

And there were four pregnancies during the study (from the abstract of the study):

During the efficacy phase of up to 56 weeks, 4 pregnancies occurred among the partners of the 266 male participants, with the rate of 1.57 per 100 continuing users (95% CI, 0.59 – 4.14)

Thanks for the correction.
in that case they wouldn't really test whether it works or not..
I don't think they were measuring the efficacy on the basis of whether or not the participants conceived - that measure is affected by too many variables. Sperm count is the more reliable metric with reasonable granularity for measuring the effect.
It's supposed to lower sperm count, which you could easily verify with a sample.
I -THINK- you didn't answer his question
> I -THINK- you didn't answer his question

Q: Anyone know how much the participants were compensated for taking part in the study?

A: To answer you question, I do not know what they were compensated.

Yes they did.

"I do not know" is not normally acceptable as an answer. The OP still does not know whether the participants were compensated.
If this was a side effect their pool was almost certainly vasectomy candidates, and rather than there being compensation, they probably didn't need to pay for their treatment.
Vasectomy still allows for IFV at a later date, intertifility doesn't.
> One volunteer did not recover within 4 years since his last injections.

It didn't say his sperm count was actually zero.

Generally IVF is still possible when the male is classified as "infertile" by traditional measures (i.e. extremely low sperm count or dysfunctional sperm).

I assume they would have at least flipped the bill for freezing sperm first.
As someone who did Phrama testing in college to help pay my way through school, compensation would be determined by how long the study went on, which the article failed to say:

"It was a pretty big study; they gave shots to 320 men every eight weeks, in different countries around the world."

Every eight weeks, but for how long?

In my experience, it would probably be in the neighborhood of a few thousand dollars, but not much more. For the participants, even that much money to take some pills over the course of say a few months would probably be seen as easy money.

But then again, there's those pesky side effects.

FYI: All the drugs I tested were already FDA approved and were not considered in a "trial" phase.

Sounds better than a vasectomy for men who want that. Good drug, wrong market perhaps.
I'm not sure that 1/320 probability of success is good for that either..
Just gotta figure out how to increase the efficacy. :)
...if it had anything to do with the study at all. What's the normal rate for infertility to develop in this demographic?
maybe they just picked guys who already had kids.

If you are considering a vasectomy anyway then it's not nearly the same problem.

Four years of infertility is probably one of the easier things you should be able to do in life.
It might be permanent infertility.
YIKES

It could be something that would have happened anyway... right? I am not an expert :P.

It's almost always a factor in such trials, AFAIK. Since it's live people that have their own lives and bodies, it could be that it happened for unrelated reasons. However, there are standards of risk and I guess "possibly makes males permanently infertile" was not an acceptable risk.
> Also important to note that permanent infertility is quite a strong side effect

I know many who would see that as a blessing though: License to have as much unprotected sex as they want without the unfortunate side-effect of an unwanted pregnancy. And they get paid for the experiment in the first place too? Win-win, they would argue.

Of course they lost the ability to have wanted pregnancy which is a pretty serious loss for some people.
> they lost the ability to have wanted pregnancy

Right, but I suspect the parent implied that this could be a feature that many would seek out - basically the chemical equivalent of a vasectomy that can't be undone.

Some people, like me, really don't want kids. Taking control of it so that you're not relying on your partner is important as trust (that they haven't forgotten to use contraception or worse - deliberately not take it) isn't a rock-solid security policy. It's also not fair on females to be the only ones in charge of contraception for bare-skin sex.

Some people, like me, really don't want kids

One thing I've learned as I've collected laps-around-the-sun is that Present Me is a poor judge of what Future Me wants.

Yeap. That's why you should never have kids, since Future Me might not want them anymore, and will be saddled with that decision from Present Me.
Ha! This is the best answer I've ever seen to the tired old "you'll change your mind one day" argument. I'm stealing this one.
Yep, it definitely goes both ways. This is definitely my greatest worry about ever having kids.
Another thing I've learned is that far too many parents take the statement "I don't want kids" as a personal challenge to moralize and condescend to people without children.
One could argue it is evolutionary advantageous for parents to do this.
You possibly underestimate my age or find it difficult to fathom why I don't want kids.
What, aside from never making any decisions (which is a itself a kind of decision), can you do other than trying to make the best decision you can right now?
The honest to goodness answer here is that you can let other people make decisions for you, and it is the desire to make decisions for other people that prompts this argument.
Exactly this! If I can take a shot or a pill rather than a scalpel to my balls... sign me up.
But it's an unpredictable side effect. It might just stop working a few years later...
So it needs work, but a chemical vasectomy would be great.
Just to clarify, they don't use a scalpel anymore (getting snipped next month).
This is a non-issue for me, but I thought it was a perspective that bears mentioning (since I hear it a lot from heterosexual men).
If you want a near-permanent way to avoid pregnancies there's already a way for that.

The many people you know that would love to be permanently infertile can get what they want in a matter of minutes, in a proven/well-known way.

> The many people you know that would love to be permanently infertile can get what they want in a matter of minutes, in a proven/well-known way.

Are you sure about that? As far as I know nearly all urologists in the US will refuse to perform a vasectomy on a childless man, especially if they're in their 20s and/or unmarried.

Not from the US and I did the procedure in my thirties, married, with two kids.

But the doctor didn't ask about any of this (he obviously knew my age). I just had to sign that I was lectured about the potential risks and consequences - similar to the preparations for any medical operation really.

And I had to agree on the price, since this (obviously?) isn't covered by basic health care here.. ;)

So.. No idea. My doctor didn't know about my marriage or kids though.

Interesting, what country? It is covered by basic health care in Canada.
Germany. You've to pay here, was around 400 Euro in total.
Then presumably they'd have the same problems with giving this injection as a means of becoming permanently infertile.
A vasectomy would've accomplished exactly the same thing with the benefit of being reversible.

So I'm guessing they're not too happy with permanent infertility.

Nota bene: Do not rely on vasectomy reversal. It may or may not work.
No babies, just HIV and herpes. Sounds like a deal.
Weird. The one comment suggesting that some participants probably see this as a feature is heavily downvoted, but the comments saying that this is shocking and awful are upvoted. I had no idea HN was so pro-birth.
Is it somehow hard to understand the difference between temporarily avoiding pregnancy and becoming permanently unable to have kids? You don't have to be "pro-birth", whatever that is, to understand how upset someone would be if they signed up for one and got the other.

Obviously these men signed up for an experimental protocol and presumably were made well aware of the risks. Nonetheless dismissing this as possibly "win-win" is spectacularly tone-deaf at best.

> understand how upset someone would be if they signed up for one and got the other.

Is it somehow hard to understand the statement that some men (not all men) would be OK with the outcome? I for one am never going to have biological children, so I don't particularly care whether I'm sterile or not.

It's not hard to understand, it's just totally irrelevant. Let's say one percent of the people taking a temporary contraceptive (rather than just having a vasectomy) happen to also not care if they are made permanently infertile. Meanwhile, another one percent get this side effect. These aren't going to be the same one percent.

The fact that there may be men in the first group is totally irrelevant to the experience of the second group.

Well, let's say you're going to have sex. _At that moment_, do you care whether you're sterile or not? Because these people probably are, but it's not certain.
Dad here, I'd downvote that too if I could. In my 20s children were the last thing on my mind; in my mid 30s, however, that changed completely.

Regardless of what one feels about children, I'm kind of shocked anyone could see accidental sterilisation as a benefit of any kind.

If permanent inability to produce offspring is what you want, there's always the snip. Of course, you'd still be subject to the risk of STDs if frequent change of partners is what you desire.

That it was accidental is always bad, but the point is that for men that were already looking into taking the snip, this was actually less invasive and possibly safer.
> Regardless of what one feels about children, I'm kind of shocked anyone could see accidental sterilisation as a benefit of any kind.

I know plenty of heterosexual men who would see this as a license to have unprotected sex with as many women as possible and never be burdened by the responsibility of a child.

I'm not saying I agree with this attitude (furthest from it, actually), but "you'll never have kids" probably won't come to them as a negative.

(I'm not hetero, for what it's worth.)

There are already simple, safe surgeries men can undergo that cause permanent infertility. I also can't see why someone would suggest this side effect is a benefit.
Have you actually talked to someone who has had a vasectomy? They are debilitatingly painful.

Sure, as a side effect, it's unfortunate, but if a pill were available that was designed for this effect it would be a blessing.

That is the most ridiculous FUD I've read in a while here.

It takes 20 minutes and you walk out. You'll feel not a thing (you might feel the injections of anesthetics). You 'recover' over a week of mostly nothing. I was riding my bike the day after the procedure.

You don't see a change, you don't feel a change and it is completely painless. Ignoring myself I've talked to a good number of friends who've done the same thing, said the same thing. I haven't heard of one single person that had a vasectomy and complained about pain in any way or form.

Honestly, I wonder why people would even wish for a 'chemical castration' all over this thread. Maybe your first line is something widely 'well known' and often repeated?

  > I was riding my bike the day after the procedure.
Please do not spread terrible medical advice which you were surely told not to do. That's great you turned out fine but it is not ethical to promote such behavior.

Think of it as someone saying their children turned out fine without immunizations. Your words can become incredibly dangerous once you begin questioning doctors if you are not trained or have added knowledge in the area of specialty.

NHS says you should avoid sport for one week.

http://www.nhs.uk/Conditions/contraception-guide/Pages/vasec...

I know somebody who had that done, he never mentioned any pain. Indeed I thought he said it was a day procedure.

Along the same lines, I know several people who have had knee replacement surgery and they all said it was the most painful thing ever. All of them though, are very happy reaping the benefits of that years later. It was only a few months after saying that if he knew it would hurt that much that he wouldn't have had it done that an 80yr old friend of mine was proudly showing me how he could jump down some steps!

Not sure what "debilitatingly painful" is based on. Personal experience? Reports from others? Guessing?

My vasectomy was not painful at all. You do get a needle into your scrotum to inject the anaesthetic, and that is not a nice feeling at all. But it's over in two seconds. You don't feel the rest, because, you know, modern medicine.

What part do you think is painful?

For me the only major downside was the cost. If I ever decide I want children, I guess I'll have to adopt.

It's not the procedure itself that is sometimes painful, it's the recovery. When I had it done more than 20 years ago, I was fine with both, but the doctor proscribed me heavy duty painkillers in case the pain got bad.

He said he didn't use to, but then he had a vasectomy himself.

I have had one. Yes it hurts. Not debilitatingly though. And it's only for a minute or so per ball. It's bruised and sensitive for a week or so, but nothing major.
> I also can't see why someone would suggest this side effect is a benefit.

Well if you can't see it, that surely must mean nobody can, right?

Not pro-birth, more like pro-not-getting-unintended-side-effects.

We don't know the test subjects or their life goals - I know that I want kids someday, but I also know that I don't want them now.

If I underwent a birth control procedure found out due to an error I couldn't have kids ever, I'd be pretty devastated.

> If I underwent a birth control procedure

This was a clinical trial, not a procedure. They don't just spring trials on you with no warning.

Also, you definitely can have kids: foster or adopt. :)

Depends what this study was about. If you were recruiting people as "try this contraceptive method", then permanent infertility is one of the most horrible side-effects possible. If, on the other hand, the focus of the study was "here are some pills that might make you permanently, or maybe just temporarily infertile", then it's fine. But then you wouldn't call it "contraceptive" or "birth control", I guess...
It's a stupid comment. An injection that has a small chance of making your infertile for an unknown amount of time, possibly forever, is useless. It's certainty that those participants need.
With that as a side effect, surely an elastic band would be a safer and more tried method. Obviously surgery would be better yet, but what they've come up with is literally worse than what we do to sheep.
You mean letting the testes shrivel up and drop off due to cut off blood flow? And it's not exactly painless.

The shot's side effects sound significantly more humane.

Boo fucking hoo.

If you really want solid male birth control with no side effects, bank your gametes for $50/mo and get your vas deferens snipped.

Female birth control may not cause permanent lack of fertility, but it can cause cancer. Breast cancer. Cervical cancer. Liver cancer.

>it can cause cancer

So can dental fillings, breast implants, and artificial sweeteners.

Like female birth control though, most people agree that the risk for developing cancer associated with the activity is well worth the benefits. Saying "boo fucking hoo" about someone who can never reproduce again is pretty cold-hearted, in my opinion.

> it can cause cancer. Breast cancer. Cervical cancer. Liver cancer.

Do you have some idea of the likelihood here? Are we talking a 10% chance of cancer or a 0.001% chance?

The whole "it can have X side effect" is the same argument anti-vaccine people use without respect to any sort of cost benefit risk analysis.

I did a quick Google and it appeared to me that most of the adverse events were measured at rates in the 10's per 10,000 ... Though that is absolutely from a very high level.

This study was presenting at around 20% (IIRC, I was reading the outrage version of this stuff a few days ago)

It is also important to note that this is by no means the end of the drug. The people involved consider this to be a very promising study and are going to continue working on it.

It wasn't stopped early "as a failure" to be shelved and never looked at again. It was stopped early because they knew enough about the upside and didn't have to continue on the down.

The next rounds of trials will likely try to alleviate the side effects while preserving the MOA (mechanism of action)

The VOX article was a reasonable balance to the "men are selfish pigs who can't handle side effects" version of this article. http://www.vox.com/2016/11/2/13494126/male-birth-control-stu...