AMA with the creators of Ovulation Double Check LIVE NOW!

[bibliothecary]

When: March 17, starting at 2:00 EDT!

Where: This thread, right here!

Why: Because this is a brand new way to check for ovulation, and we know you ladies love science!


This thread will be unlocked 10 minutes prior to the live chat starting so that you can begin to post questions.



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5) If you have any doubts about something, please feel free to PM bibliothecary


Because lawyers and such: These statements have not been evaluated by the Food and Drug Administration. Ovulation Double Check is not intended to diagnose, treat, cure, or prevent any disease or condition. We are not physicians, consult your doctor if you have irregular or unusually long cycles.

[NariaDreaming]

Thank you, mfbfertility for joining us today so we can learn more about how you are hoping to change the face of at-home testing

[IFinTN]

Bueller? Bueller?

[bibliothecary]

I've got a question!

How did you come up with the idea to track progesterone? Why haven't the "big guys" done this yet?

[sassypantzz]

Can you tell me the basics of how this is used?

[butlerfan]

How much progesterone is needed to confirm ovulation for your test?

[mfbfertility]

Mar 17, 2016 13:01:06 GMT -5 bibliothecary said:

I've got a question!

How did you come up with the idea to track progesterone? Why haven't the "big guys" done this yet?

When I was TTCing, I could not get positive OPKs and had trouble tracking my temps. I knew that the temp increase after ovulation was due to the presence of progesterone. So, I started doing some research and found I could develop a test to measure progesterone in urine and thought that would be an easier method to track ovulation. Can't tell you how many times I wanting to throw that thermometer out the window!

[athn64]

Is your product supposed to replace traditional OPKs or be in addition to them for helping pinpoint ovulation?

[IFinTN]

Mar 17, 2016 13:01:06 GMT -5 bibliothecary said:

I've got a question!

How did you come up with the idea to track progesterone? Why haven't the "big guys" done this yet?

Part 2 "why haven't the big guys done this yet?

The technology has been known for a long time to track the metabolites of progesterone in urine. It was part of a long expired patent.

We know some digital tests actually use fsh, hcg and progesterone testing and they all have to be positive to give a positive outcome. (Clearblue has patented it but it is not on the market yet).

We think the big guys are worried about market share for this test. Also, because in order to make the test work, it has to be 1 line=positive result and that is counterintuitive. They may think consumers will be confused by it.

We can only speculate that the big guys don't feel it is worth the financial investment to bring the product to market.

[mfbfertility]

Mar 17, 2016 13:01:06 GMT -5 sassypantzz said:

Can you tell me the basics of how this is used?

This test is used as a way to measure progesterone in urine. Progesterone is elevated after ovulation. So, once you get an LH surge and/or temp increase, or any other indicator, you can use the Ovulation double check to check progesterone levels. If the test is positive, it is a good indication you have ovulated already. 

After 2 years of having sex all the time, I really wanted to know when it saw safe to take a break until next month =)

[mfbfertility]

Mar 17, 2016 13:05:13 GMT -5 butlerfan said:

How much progesterone is needed to confirm ovulation for your test?

Great question. After ovulation the concentration of progesterone metabolites in the urine goes from <2umol to 20umol (peak level). Our tests are designed to give a positive result with 7umol or higher.

[requiressnacks]

If a person doesn't get a positive for the presence of progesterone, should a person automatically think that they did not ovulate? Or is this kind of like OPKS - you can never get a positive, but still ovulate? (sort of like a double check?)

[sassypantzz]

What are you hoping will be the price point of these tests once they are on the market.

[butlerfan]

Follow up to my other question:
Is this close to the same amount needed to confirm for blood work...ie going to your RE?

[IFinTN]

Mar 17, 2016 13:05:48 GMT -5 athn64 said:

Is your product supposed to replace traditional OPKs or be in addition to them for helping pinpoint ovulation?

This is meant to be part of your TTC arsenal. Use the OPKs, cervical mucus, temping or whatever you want in addition to these tests.

However, for those with PCOS, LH strips can be pretty worthless since LH always runs high. Often times it takes a blood test 7dpo to confirm ovulation and you have to guess when you are 7dpo. This way you can monitor at home.

Our targeted cost is under $20 for 7--so cheap enough to use frequently and usually cheaper than a blood test.

[NariaDreaming]

For women who aren't temping, how many tests do you think they would need on hand each month?

[IFinTN]

Mar 17, 2016 13:14:52 GMT -5 sassypantzz said:

What are you hoping will be the price point of these tests once they are on the market.

Our target is 7 tests for about $20. So cheap enough to use frequently and hopefully cheaper than multiple blood tests.

Obviously, if it is wildly successful, we can take advantage of economies of scale and they can be like the wondfo cheapie LH and HCG strips.

[IFinTN]

Mar 17, 2016 13:15:45 GMT -5 NariaDreaming said:

For women who aren't temping, how many tests do you think they would need on hand each month?

Great question. It depends on how regular your cycle is, we anticipate the average woman would use between 5-7 per cycle (which is how we plan to sell them).

[mfbfertility]

Mar 17, 2016 13:14:08 GMT -5 requiressnacks said:

If a person doesn't get a positive for the presence of progesterone, should a person automatically think that they did not ovulate? Or is this kind of like OPKS - you can never get a positive, but still ovulate? (sort of like a double check?)

Excellent question! Progesterone in an oil-soluble hormone and therefore it gets secreted in the urine at different rates, unlike estrogen and hcg which is water-soluble. Therefore it is possible to get a negative result for progesterone and still have ovulated, however, since our limit of detection is so low (see previous post) this rarely happens. We are trying to make these tests cheap enough to use several during each cycle. If you believe ovulation has occurred, we recommend re-testing in 3-4 hours with fresh urine.

[IFinTN]

Mar 17, 2016 13:19:43 GMT -5 @buttmonkey said:

Hello!

I have a question with regards to progesterone levels once a pregnancy has been achieved. Will this be able to test progesterone levels in the first 8-10 weeks of pregnancy (i.e. so an FET or IVF patient doesn't have to wait week to week for blood draws, or wants confirmation once the RE is no longer testing P4 levels)?

It is difficult to get a quantitative response due to the way the hormone is secreted in your urine. Our tests are currently considered qualitative with a lower end cut off. 

[bibliothecary]

You mentioned the two lines meaning a negative being counter intuitive. Is there a reason why the lines have to disappear, rather than appear?

[athn64]

What has been the most difficult part in getting these made so far?

[sassypantzz]

Specifically what makes these different that your standard OPK other than a lower read level?

[mfbfertility]

Mar 17, 2016 13:15:12 GMT -5 butlerfan said:

Follow up to my other question:
Is this close to the same amount needed to confirm for blood work...ie going to your RE?

Yes, but their are a few differences. Our test measures urine metabolites of progesterone and a blood test measures progesterone so the concentrations of metabolites are slightly different. Serum concentration for progesterone before ovulation are <1ng/ml and elevate to 5-20ng/ml after ovulation.

[IFinTN]

Mar 17, 2016 13:26:55 GMT -5 athn64 said:

What has been the most difficult part in getting these made so far?

The science is solid--I'm letting mfbfertility go into more detail in answering the one line vs. two line reasoning.

The tests will not require FDA approval as they are exempt even though we could certainly seek approval if we wanted as a rubber stamp.

HOWEVER, we do have to use an FDA approved GMP facility to optimize, manufacture and package the tests. That costs money that we don't have. 

Part of our crowdfunding campaign is to determine if the market wants these tests. If the "big guys" are right and there really is no market, then we are at the end game.

[mfbfertility]

Mar 17, 2016 13:26:16 GMT -5 bibliothecary said:

You mentioned the two lines meaning a negative being counter intuitive. Is there a reason why the lines have to disappear, rather than appear?

Yes, this is very counter intuitive we know. We tried really hard to get the 2 lines = positive type of test going but the progesterone metabolites are too small to be detected that way. Typical hcg and lh tests use what is called a "sandwich" method. In order to track progesterone, we had to use the "competitive" method. If you're interested in learning more about the two different methods I urge you to goolge "Sandwich ELISA vs Competitive ELISA"

[IFinTN]

Mar 17, 2016 13:29:00 GMT -5 sassypantzz said:

Specifically what makes these different that your standard OPK other than a lower read level?

Great question. OPKs look for your surge in LH that indicates ovulation is about to occur. After ovulation, you get a rise in progesterone, which is what this test measures (specifically a metabolite of progesterone that is secreted in your urine). 

You can get an LH surge without actually ovulating and several surges in one cycle. So if you get a positive OPK and then never get a positive Ovulation Double Check (ODC) test, it is highly likely you did not ovulate. This is very important information to take to your doctor if you are having trouble TTC.

[BunnyBerry]

It's actually traumatizing how many times I kept having sex when I'd have preferred to take some nights off because I couldn't be entirely sure if my temps showed ovulation yet. I'm wondering, how many days after actual ovulation do you anticipate the strips would show a positive result for most women?

[mfbfertility]

Mar 17, 2016 13:36:55 GMT -5 mfbfertility said:

Mar 17, 2016 13:26:16 GMT -5 bibliothecary said:

You mentioned the two lines meaning a negative being counter intuitive. Is there a reason why the lines have to disappear, rather than appear?

Yes, this is very counter intuitive we know. We tried really hard to get the 2 lines = positive type of test going but the progesterone metabolites are too small to be detected that way. Typical hcg and lh tests use what is called a "sandwich" method. In order to track progesterone, we had to use the "competitive" method. If you're interested in learning more about the two different methods I urge you to goolge "Sandwich ELISA vs Competitive ELISA"

I also think that the "big guys" don't think a typical women can understand how to read these types of tests and that was a driving force behind them not producing and marketing them. We on the other hand think women are wicked smart and deserve to have these tests available to them!

[IFinTN]

Mar 17, 2016 13:41:30 GMT -5 BunnyBerry said:

It's actually traumatizing how many times I kept having sex when I'd have preferred to take some nights off because I couldn't be entirely sure if my temps showed ovulation yet. I'm wondering, how many days after actual ovulation do you anticipate the strips would show a positive result for most women?

I LOVE this question--but I'm gonna let mfbfertility answer it