In 2020, people spent over 250 million dollars
on over the counter fertility tests such as ovulation predictor tests. There is limited
evidence that these costly kits help improve the chances for pregnancy for most people.
Watch this video for more information about that. Unfortunately, some companies have
resorted to misleading advertising to capture your hard earned money. Today, on InfertilityTV,
I am going to review some of these products and reveal the actual science behind them.
Joy Pie asked my opinion about a urine test from a company called Proov. According to their website,
they claim to be able to determine “ovulation quality” with a urine test for a hormone called
PdG and that a clinical study shows that elevated PdG on specific days after suspected ovulation
(during the implantation window) is associated with a 92% chance of successful pregnancy,
compared to only a 19% chance in those with lower PdG levels.
Lets look at this claim more closely. After ovulation, the corpus luteum in the ovary
produces a huge amount of progesterone. Progesterone is responsible for preparing
the uterine lining for implantation and then maintaining it afterward. Eventually,
progesterone in the blood circulates through the liver where it is changed
or metabolized into over 30 different molecules. One of those molecules, PdG,
is eventually excreted from the kidneys where it can be measured in the urine. Before ovulation,
progesterone levels in the blood are low and PdG levels in the urine are low. After ovulation,
progesterone levels in the blood are high and so PdG levels in the urine also get higher.
Do PdG levels in the urine indicate “ovulation quality”? First of all, that is a made up term.
There is no medical or scientific concept of ovulation quality. Ovulation is the release of
an egg from the ovary. A person either ovulates or not. There is no “quality” of ovulation. What
about that study? I reviewed that study closely. That study did not look at PdG levels “during the
implantation window” as they claimed but rather it looked at PdG levels in people that were already
pregnant! PdG was being used as a method to monitor pregnancies in the 1st trimester. That
study, by the way, was published a long time ago - 1978. Today, we have much better ways
to monitor pregnancies, for example, with hCG blood tests and ultrasounds. That study had 76
pregnant people collect all their urine for 24 hours on 4 separate occasions, not just a one
time collection such as this one. There is no evidence that the two methods are equivalent.
What about other studies? There have never been any clinical studies which proved that
measurement of urinary PdG helps identify people who are more or less likely to become pregnant.
Most of the studies in this area are of poor quality. The best study is this one from the
National Institutes of Health from 1999, which studied 215 healthy ovulating women!
This was a comprehensive study that looked at a number of urinary hormones. However,
they did collect a single urine specimen during the implantation window and tested the PdG level.
They compared the PdG levels in months where pregnancy occurred and months where it did not
occur. They found that PdG levels were no different. Thus, the claim that this test
helps determine the “quality of ovulation” is not supported by the scientific data.
Can it be used just to determine if ovulation occurred? Yes. But its not as accurate as
existing methods. Compared to using a home urine LH kit or even just looking at cervical mucous,
this study found that urinary PdG testing missed ovulation anywhere from 5% to 15% of the time.
This study found it missed ovulation 19 to 41% of the time.
Another section on their website that some would think is misleading is their claims
about what FDA Clearance means. The implication I had from reading this is that the FDA has
performed a detailed review of the claims and agrees with those claims. This is not true.
All FDA clearance means is that the technology used for this test is similar to a device that
has already been cleared, in this case, a saliva test for progesterone. In fact,
the FDA explicitly states that clearance “does not in any way denote official approval of the device.
Any representation that creates an impression of official approval of a device because of complying
with the premarket notification regulations is misleading and constitutes misbranding.”
Another test for sale on this site was a urinary FSH test.
FSH is a hormone from the pituitary gland. Blood levels of FSH are used by infertility doctors
to help identify which people with infertility may have a low reserve of eggs remaining. People with
low ovarian reserve do not respond to fertility medications as well, and with treatments like IVF,
have higher cancellation rates and therefore lower success rates. There is no data that
urinary FSH testing is of any benefit in assessing ovarian reserve. In fact, this study looked at
several hundred people without infertility and looked at their urinary FSH levels. They compared
people with abnormally high levels of urinary FSH to people with normal levels. After 6 months
and after 12 months, there was no difference in the number of people who became pregnant
based on their urinary FSH levels. In other words, urinary FSH is a completely useless test.
This company also sells supplements. One supplement is called Luteal Love which is
an herbal blend that supports your body’s progesterone production. This contains
some common and completely unproven herbal supplements. In this episode,
I discussed the fact there is no data showing any benefit to these supplements
and that there are very real risks to using them. For example, the ashwagandha in this supplement
is frequently contaminated with industrial chemicals like lead, mercury and arsenic.
This other product they sell called “Balancing Oil” contains progesterone drops that are applied
to the skin. Progesterone absorption from the skin is highly variable depending on where it
is applied, what the progesterone is mixed with, the dose and the frequency. It has never been
shown to be of benefit for people with fertility problems. Although they do not directly state this
on their website. When I wrote to them to ask if they had any data about it improving fertility,
they replied that "we do not keep track of that information as it falls outside of our
intended use of it being a cosmetic to enhance beauty. It is clear that
infertility patients are who they are trying to sell this to. They prominently mention that
this is “fertility doctor advised” and they have fertility experienced customer support.
Our infertility TV bottom line is this. Many companies will try to prey on your desperation
to get pregnant to sell you useless tests and treatments. It is important that you be an
educated consumer and don't waste your money. For more information
check out our fertility scams playlist for other things to avoid.