Low numbers with 12494
ensimp1
Posts: 3
Hi! Has anyone used 12494 and gotten low numbers?
We just did our first IUI and I almost burst into tears when I saw the numbers. The prewash (we used ICI as our RE wanted to down their own wash) for two vials was 49 million with only 21% motility which worked out to 9 million motile prewash. Obviously, that was way below the promised motility for two vials which should have been 30 million (+/- 10 million given the stated wiggle room of 15-30%). After wash it was only 6 million. After all the waiting and anticipation to start this process, I honestly thought I was going to be sick.
Has anyone else used this donor? What have your numbers been like? I'm wondering if we need to switch or this was just a particularly bad vial.
We just did our first IUI and I almost burst into tears when I saw the numbers. The prewash (we used ICI as our RE wanted to down their own wash) for two vials was 49 million with only 21% motility which worked out to 9 million motile prewash. Obviously, that was way below the promised motility for two vials which should have been 30 million (+/- 10 million given the stated wiggle room of 15-30%). After wash it was only 6 million. After all the waiting and anticipation to start this process, I honestly thought I was going to be sick.
Has anyone else used this donor? What have your numbers been like? I'm wondering if we need to switch or this was just a particularly bad vial.
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Comments
Before contemplating the number of sperm in a vial, it’s important to keep in mind that numerous studies find that pregnancy rates with intrauterine insemination are maximized with 5 million total motile sperm. In other words, 5 million and 50 motile sperm offer the same chance of success. California Cryobank established vial standards to well-exceed the number of sperm required to achieve pregnancy.
The CCB vial standards refer to the total motile sperm. The total motile count is calculated by multiplying the percentage of motile sperm by the number of all sperm counted. A standard ICI vial contains a minimum of 15 million total motile sperm after it’s been thawed, prior to washing. A standard IUI vial contains a minimum of 10 million total motile sperm after it’s been thawed, with no wash necessary. We perform a post-thaw count on one vial from every lot to confirm the sperm survive the freezing process and still meet our high standards.
Sperm are living, moving cells, and under the best of circumstances the calculation of total motile sperm count can vary by 20%. When vials are evaluated in a doctor’s office, additional variables, such as amount of time the specimen is thawed, the individual doing the counting, and the type of counting chamber used, can significantly affect the total motile sperm concentration result.
CCB uses a device called a Makler chamber to count sperm under a microscope. This counting chamber has a large depth of field that allows technicians to evaluate a three-dimensional drop of sperm. Many clinics use a system that relies on disposable slides. Disposable chambers sandwich a drop of the specimen between two slides, pushing much of liquid to the edges. While these slides are a perfectly acceptable means for evaluating a sperm sample, they are known to produce counts that are 30% lower than those derived from the Makler. One must take into consideration an adjustment for this difference when comparing calculations based on the disposable slides to those produced using a Makler chamber.
Normal motility for a once frozen sperm sample is any fraction above 20%. Once thawed, sperm takes some time to "wake up" and start moving again. As a result, motility actually increases after insemination as more sperm adjust to the ideal 98.6-degree environment. It is preferable to have sperm under-thawed prior to insemination. If they are over-warmed, they are more likely to die quickly. Most specimens that appear to show poor motility immediately after thaw are actually ideal once used for insemination.
The important thing to take away from this long answer (sorry if it is too much information) is that you have not lost a cycle. Your chances of success are exactly the same as they would have been with 50 million total motile sperm.
That said, please have your physician submit a specimen report form so we can investigate your specific situation and issue any necessary credits.
Best of luck,
Jaime Shamonki, MD
Medical Director
It's not too much information; however, calculating the worst case scenarios (20% natural variation and 30% for a non-Makler method), I would expect the numbers to be no less than 7.92 million motile sperm per ICI vial. Obviously, a post thaw total, combining two ICI vials prewash, of 9 million motile sperm would clearly be below what would be the expected worst case scenario of approximately 15 million between two vials.
My understanding of the literature on the topic of total motile sperm is that there is a statistically significant difference with success rates when the total is below 10 million motile sperm (and even more so below 5 million) though no statistically significant difference when the number is higher than that. Am I in error?
Although the post served something of a cathartic purpose, I really would like to know if others have had a similar experience with this donor as we made the choice to use California over a similarly reputable but closer competitor given the promise of guaranteed counts.
Please see the response below from our medical director, Dr. Jaime Shamonki.
Regards,
Nicole
CCB
Regarding the question of total motile sperm in the literature:
CCB has been very interested in the concentration of total motile sperm (TMS) required to achieve acceptable pregnancy success rates for almost 40 years. One important thing to keep in mind when you are reading the literature on this subject is that donor sperm and partner sperm are considered quite different. When looking at large populations of study participants, greater quantities of partner TMS are generally required to achieve pregnancy.
The idea of identifying an “efficacy threshold” is clearly artificial, though this is how we have to approach the question to ultimately determine our vial standards. Most studies analyze outcomes by <2M, 2-5M, 5-10M, >10M TMS. You are correct that historically 10M TMS was considered the accepted standard. Over the last 20 years, the literature has shifted to generally agree that 5M motile sperm, and more recently 2M motile sperm (donor sperm) show no significant differences in pregnancy when compared to higher quantities.
A 2001 study determined there are 5 predictive variables for the outcome of intrauterine insemination with donor semen in terms of clinical pregnancy rate: Number of treatment cycles, number of mature follicles, the cycle day for insemination, the occurrence of ovulation at the time of insemination and the age of the woman. This study showed no significant difference in pregnancy rate for TMS > 2M.
For this reason, we feel very comfortable with the assertion that anything greater than 5M donor TMS does not improve pregnancy outcome. Our vial standards are set generously above this mark to allow for the margin of error I’ve previously described and you have correctly understood.
With this said, I do encourage you have your laboratory submit a specimen report form. We always are interested in feedback from clients and strive to collaborate with all of our partner laboratories to help resolve these issues.
To specifically address your question regarding other clients' experience with this donor: 2% of the vials sold from this donor have been reported to us as unsatisfactory based on calculated TMS in the vial. This is the same percentage of all vials we traditionally receive claims on annually (par for the course), so I would not conclude that there is any reason to question the donor you have chosen. I don't want to be mistaken here: 2% expected claims does not equate to actually substandard production of 2% of our vials, rather it is a predictable rate of claims based on the many variables involved in assessing vial contents after we send it out into the world.
I hope this information is helpful to you.