BabyStart™ - New Fertility Screening Test for Men

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Roberta Speyer: "Hello, this is Roberta Speyer reporting for OBGYN.net. We're here at the ESHRE Conference in Lausanne, Switzerland. It's July 3, 2001, and I'm with Dr. Robert Barlow and his wife Gwen and they have a company called…"

Gwen Barlow: "Med-Direct International."

Roberta Speyer: "Med-Direct International but this does not truly tell you what's very interesting about this. This is something that will be coming out in the United States, hopefully, very soon on the market and they have products for testing for fertility cycles and pregnancy tests but the new product that's really exciting and interesting is a product that's not for the woman but for the man. Which one of you would like to tell me a little bit about that?"

Dr. Robert Barlow: "I think I should do that."

Roberta Speyer: "Robert, go ahead."

Dr. Robert Barlow: "Thank you. We're very excited about this product because for the first time it gives us an opportunity to give not only advice, which we've been doing for some years, but to actually encourage men or couples to see the first line screening of the man to see whether his sperm concentration is more than 20 million per ml or not. If it's more than 20 million per ml then that's a good sign that it's worth continuing to try and conceive. If it's less, you really should be getting along to see a doctor. It's just a five minute test and we're ready to introduce it."

Roberta Speyer: "This is a home test, correct?"

Dr. Robert Barlow: "Yes, definitely."

Roberta Speyer: "This is what's really unique, this is a test that's often been done and needs to be done if a couple is having prolonged infertility problems but usually what happens is the doctor tells people to keep trying. How long before they start going into the office and having these types of tests? How long does that usually go on?"

Dr. Robert Barlow: "Typically, one year, that's the big difficulty with infertility, the couples are constantly told to go away and keep trying for ten or twelve months. What we offer in a product which we call 'BabyStart™' for obvious reasons is if a couple is planning to have a baby, if they screen the man with this new test, if they use an ovulation predictor kit, and if they understand a little bit of timing of ovulation and fertility for the woman - then they really ought to conceive within three or four cycles. That's the good news."

Roberta Speyer: "Do you have a website that tells about this BabyStart™?"

Dr. Robert Barlow: "We do, we have a number of websites but I think the best one would be www.med-direct.co.uk." 

Roberta Speyer: "You have both also spent quite a deal of time interacting with your clients and the families you help on the Internet. Why don't you tell us a little bit about your work in that area, Gwen."

Gwen Barlow: "That's correct, the website's been going for three or four years now. At first we were just selling the female test but we give a lot of information on the site about ovulation, menstrual cycles, and now also male fertility. We have a care line so you can e-mail in to us and you'll get expert advice and information that way also."

Roberta Speyer: "This is a very stressful time for people when they're having these problems. Just going to the corner chemist or pharmacy - for those of us back in the United States - and going in and trying to buy these products it's difficult to know how to use them or what it is you're trying to achieve. I also think there's an interesting point about the male test, one would imagine there tends to be because of the way in order to get a sample, you have to get ejaculate and so for a man to go to the doctor and have to go through that procedure must be uncomfortable."

Gwen Barlow: "That's right."

Roberta Speyer: "And so they probably put it off - what's been your experience in that regard, is that the way that happens?"

Gwen Barlow: "Yes, absolutely and it can take a man quite a long time until he'll agree to go and have a test done. Not only does the home test give you privacy but you also can do it naturally as the kit contains non-spermicidal condoms."

Roberta Speyer: "So it takes a lot of that stress out of it. Let me understand this, if you have the right sperm count you could still have other problems such as sperm motility problems or other problems but this is a first line because if you don't have the count then what do you do?"

Dr. Robert Barlow: "Then, definitely, medically you need to go for an examination. I think it's pretty important, these screening tests are just screening tests but if you have less than 20 million per ml sperm then every doctor will tell you that you need to go for more investigation."

Roberta Speyer: "Have you made an application for FDA approval at this point?" 

Dr. Robert Barlow: "Yes the product was developed and…"

Roberta Speyer: "By the way, where was the product developed?"

Dr. Robert Barlow: "At Harvard University."

Roberta Speyer: "Really, very good."

Dr. Robert Barlow: "FDA submission is in and if that's as successful as we hope it will be then BabyStart™ should be available in the U.S., I think, well before the end of the year which would be great news for couples starting."

Roberta Speyer: "That's very good news for couples. I'm curious, who was the doctor who developed it?"

Dr. Robert Barlow: "Dr. Juan Alvarez at Harvard was an important figure."

Roberta Speyer: "Were there were clinical trials done on this?"

Dr. Robert Barlow: "Yes, three typical three-center trials and evaluations."

Roberta Speyer: "How big a group was it?"

Dr. Robert Barlow: "I think, overall there was in excess of 200 people in it tested and the results, certainly looking at it from our view, is this is a perfectly valid home test."

Roberta Speyer: "Very good, I thank you both so much for being here with us today. Enjoy the rest of the conference."

Gwen Barlow: "Thank you, same to you too."

Dr. Robert Barlow: "Thank you very much."