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Please keep this away from my cervix.

Of course this is FDA approved.

A conception kit.

Posted by Samhita - August 11, 2006, at 07:19PM | in Reproductive Rights

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14 Comments

The semen collectors are CONDOMS!!! The Semen cup looks like either a cervical cap or a menstrual cup. The whole thing gives me the willies.

I feel torn about stuff like this, knowing people who have struggled to have a baby. But in concert with the "Pre-Pregnant" status thing, and the forced birth movement, this is scary.

Oh, I just went back and saw that the Conception Kit can help overcome a "Hostile Vaginal Environment"!!!

What grossed me out is there's something that comes with the conception cap called "pre-seed." Ew!

lavalady:

A "hostile vaginal environment" is actually a frequently used phrase for a vagina with a bacteriological or pH imbalance, or with issues with inflammation or cervical mucus thickness.

I don't intend to comment on the effectiveness or creepiness of this product, but there's nothing particularly wrong with that phrase, and it looks fairly easy to verify the safety of the system.

[0+] Author Profile Page MsJane said:

I see nothing wrong with this product if a woman is having difficulty conceiving. It might even be a useful alternative product for lesbian parents to use if they are practicing self-insemination at home.

Sure, there's nothing wrong with using a condom to catch some semen, pouring it into a diva cup and then cramming it next to your cervix if you want to give those sperm a boost. However, I find the $300 price tag (But am I too harsh? It's a special introductory price) for a "three month supply" of pregnancy tests, wheel calendars, condoms and lubes to be a bit steep. All of these products are easily available for a lot less money. Since a couple who is struggling with infertility to the point where they would start looking at stuff like this will probably not concieve in three months, I'd have to assume people would buy two or three or more of these "kits" before they either succeeded or gave up and tried something more involved. Charging that much money for simply assembling a kit of shit you can get at the drugstore seems a bit shady.

[0+] Author Profile Page MsJane said:

The price is another matter. The point of discussion was the efficacy of the product, and for some, the apparent ick factor.

The cup is evidently FDA approved and designed to safely attach to the cervix in a way which does not scar or harm and is easily removed. The condoms supplied are specific because they do not contain latex or spermicide.

The price seems reasonable in this market, given the goal. Couples spend thousands to conceive. This is a do-it-yourself product. If you obtained the aid of a medically trained person to come to your home, and inject sperm into the uterus, it would cost money. If you went to a doctor's office it would cost money. It you went through a medical procedure with the doctor it would cost big money.

If there are other products on the market which work just as well for less money then the free market will take care of that. I suppose we don't have to spend hundreds of dollars in designer make-up, moisturizers, clothes, dry-cleaning fees, etc...when we could possibly make our own products at home, buy at rummage sales, and clean our own silk blouses. It's all perspective.


[0+] Author Profile Page EG said:

It's not that hard to find non-latex, non-spermicidal condoms--I pick them up at my local drug store, and it's even easier to find them on-line. I don't know about non-latex diva cups, but I have to ask: what is this about their cup not scarring or harming the uterus and being easy to remove? Do diva cups, cervical caps, and diaphragms usually scar or harm the uterus? I tell you, my doctor didn't mention it when I had a diaphragm. It was, I must admit, a pain in the neck to remove, though.

[0+] Author Profile Page MsJane said:

EG, I am not suggesting that those products cause scarring. What I'm saying is that if I was going to try a *new* product that I had to put on my cervix I would want to know it was safe. Which they claim it is. As far as caps and other devices, I have no idea if they have a potential to cause scarring. I can tell you though that I have some scarring and have never figured out where it came from. I never gave birth, had a D&C or had an STD. So I'm wondering about products, I suppose.

[0+] Author Profile Page EG said:

Sorry, Ms. Jane, the snarky tone in my post was not meant to be directed at you, but I see now that I didn't make that clear. My "what's this about" was more directed at the absent copy-writers for the conception kit; I am equally ready to believe that either a) diaphragms etc. don't cause scarring or harm and the copy-writers are indulging in a bit of fear-mongering or b) that doctors have not been informing us of the potential consequences of using diaphragms etc. I just wonder which it is...

EG, I am not the absent copy writter but am the patent holder of the Conception Cap.

I want to preface this by saying that everyone is free to choose any treatment program that they would like. However this is the very first time that the FDA has approved a cap for this purpose.

As part of the process the FDA required us to put the material in the cap in contact with semen to ensure no change in moltility, count and morpology and also required it to be place in contact with cervical mucus to make sure it did not change the permeability of the mucus (many chemicals will make the mucus "hostile" or less permeable.

The FDA then required everything to be repeated using bovine end points. Using bull semen we tracked sperm which had been in contact with the cap through the mucus and fertilized bovine oocytes. They were taken out 7 days and then stained to ensure that the material that composed the conception cap did not in any way effect early cell division.

This process was repeated on the tray that holds the conception cap to ensure there is no cross contamination from the packaging material.

The design of the cap itself was a challenge as it had to be able to concentrate the semen at the opening of the cervical OS.

Contrary to the belief of most men the volume of normal ejaculate is 1 to 5 ml...therefore in order to effectively concentrate this rather small amount of fluid a device smaller than a Diva or Instead had to be designed...another problem manifest with wide mouthed devices is that they act like scoops, so if there is a yeast infection etc. a slurry is made which defeats the purpose.

Also a device that actually fits on the cervix and not just lodged in the vaginal cavity would concentrate lower amounts of semen better. And it had to be able to accomodate women in secondary ferility problems as well. (all with one size)

I also believe that you may have misread the references to scarring...a scarred uterus (which cap insemination can not over come) would be a result of a low grade infection or an STD in the uterus which remains untreated...an embryo can not implant on scar tissue thereby reducing the odds of becoming pregnant.

But to answer the second part of your questions about what doctors tell you...it depends on the material of your diaphragm...latexis a terrible carbon based bio material will support bacterial growth and will also cause tissue erosion over time. Latex diaphragms are not nearly as "friendly" as silicone ones.

I would also disagree with statement that condoms for this use are readily available...having done extensive testing the only commercially available condom which falls into an acceptable bio-compatability standard for the semen and the mucus is the Avanti by Durex...

As consummers you need to be aware of what is formulated into the base materials...for example the Trojan Supra uses a different kind of polyurethane that is less supple so they formulate N-9 into the polyurethane to make it softer.

We were not happy with what was out there and we are inthe process of seeking FDA approval on out own semen collector.

Also in order to answer the KIT question...the European Community and Health Canada would not approve the Conception Cap for home use unless it was included in a kit...their concern, rightly or wrongly is that someone would use a "glow in the dark condom" to collect semen and then transfer it to the cap and have a baby with a birth defect...they required that all components have regulatory approval for the purpose intended.

For example the Instead is made of a polyethelene with mineral oil and pink dyes added and then out side a clean room, placed in contact with a purple dyed plastic package...none of these materials or dyes have been demonstrated to be free of any agents which may hinder conception or cause birth defects.

At the end of the day there are many things that people can do...some have regulatory approval for safety and efficacy and some are urban legends.

The Conception Kit is 299 for 3 months including shipping and product liability insurance and FDA approval...that is 100 dollars a try, to know everything has been tested and certified...

There are new products coming on line which are legitmate products that have FDA approval...

Another example is at www.embryotech.com Their home sperm assay is FDA approved...they too are the only one.

The market will determine if there is a place for FDA approved products couples can use at home.

Like home sperm assays, conception caps and now the home std tests...I think these actually provide more control to the patient not less and is a positive trend.

Michael La Vean


EG, I am not the absent copy writter but am the patent holder of the Conception Cap.

I want to preface this by saying that everyone is free to choose any treatment program that they would like. However this is the very first time that the FDA has approved a cap for this purpose.

As part of the process the FDA required us to put the material in the cap in contact with semen to ensure no change in moltility, count and morpology and also required it to be place in contact with cervical mucus to make sure it did not change the permeability of the mucus (many chemicals will make the mucus "hostile" or less permeable.

The FDA then required everything to be repeated using bovine end points. Using bull semen we tracked sperm which had been in contact with the cap through the mucus and fertilized bovine oocytes. They were taken out 7 days and then stained to ensure that the material that composed the conception cap did not in any way effect early cell division.

This process was repeated on the tray that holds the conception cap to ensure there is no cross contamination from the packaging material.

The design of the cap itself was a challenge as it had to be able to concentrate the semen at the opening of the cervical OS.

Contrary to the belief of most men the volume of normal ejaculate is 1 to 5 ml...therefore in order to effectively concentrate this rather small amount of fluid a device smaller than a Diva or Instead had to be designed...another problem manifest with wide mouthed devices is that they act like scoops, so if there is a yeast infection etc. a slurry is made which defeats the purpose.

Also a device that actually fits on the cervix and not just lodged in the vaginal cavity would concentrate lower amounts of semen better. And it had to be able to accomodate women in secondary ferility problems as well. (all with one size)

I also believe that you may have misread the references to scarring...a scarred uterus (which cap insemination can not over come) would be a result of a low grade infection or an STD in the uterus which remains untreated...an embryo can not implant on scar tissue thereby reducing the odds of becoming pregnant.

But to answer the second part of your questions about what doctors tell you...it depends on the material of your diaphragm...latexis a terrible carbon based bio material will support bacterial growth and will also cause tissue erosion over time. Latex diaphragms are not nearly as "friendly" as silicone ones.

I would also disagree with statement that condoms for this use are readily available...having done extensive testing the only commercially available condom which falls into an acceptable bio-compatability standard for the semen and the mucus is the Avanti by Durex...

As consummers you need to be aware of what is formulated into the base materials...for example the Trojan Supra uses a different kind of polyurethane that is less supple so they formulate N-9 into the polyurethane to make it softer.

We were not happy with what was out there and we are inthe process of seeking FDA approval on out own semen collector.

Also in order to answer the KIT question...the European Community and Health Canada would not approve the Conception Cap for home use unless it was included in a kit...their concern, rightly or wrongly is that someone would use a "glow in the dark condom" to collect semen and then transfer it to the cap and have a baby with a birth defect...they required that all components have regulatory approval for the purpose intended.

For example the Instead is made of a polyethelene with mineral oil and pink dyes added and then out side a clean room, placed in contact with a purple dyed plastic package...none of these materials or dyes have been demonstrated to be free of any agents which may hinder conception or cause birth defects.

At the end of the day there are many things that people can do...some have regulatory approval for safety and efficacy and some are urban legends.

The Conception Kit is 299 for 3 months including shipping and product liability insurance and FDA approval...that is 100 dollars a try, to know everything has been tested and certified...

There are new products coming on line which are legitmate products that have FDA approval...

Another example is at www.embryotech.com Their home sperm assay is FDA approved...they too are the only one.

The market will determine if there is a place for FDA approved products couples can use at home.

Like home sperm assays, conception caps and now the home std tests...I think these actually provide more control to the patient not less and is a positive trend.

Michael La Vean


[0+] Author Profile Page MsJane said:

Michael I don't know where you came from, but that was very informative, thank you.

You might be interested to know that women with fertility issues and lesbians using donor sperm have been doing this for AGES with those Instead cups.

Much more cheaply, it appears.

[0+] Author Profile Page kgsavoie said:

While I can totally understand the bitterness over the fact that this is FDA-approved, while Plan-B lingers in FDA-limbo (any developments on that? I've been under a rock of my own making...) I read Michale La Vean's response (and googled the name as a cursory nod to fact-checking) and it seems to add up. As a lesbian who may be looking forward to a long road of alternatives to heterosexual sex for insemination purposes, I've book-marked the info.

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