Ovulation Double Check is an at-home urine test that will detect the presence of progesterone, a hormone that indicates ovulation has taken place.
Amy Beckley and her business partner, patent lawyer Christina Chamberlain, are working on the test under their Erie, Colorado-based company, MFB Fertility Inc., which is dedicated to supporting fertility and young children. Beckley also is working on a quantitative test that would read more specific progesterone levels.
The duo launched a crowd-funding campaign in March to support production of Ovulation Double Check. As of April 27, they had met 92 per cent of their $28,000 goal. The campaign is to end May 12.
"I can see that the need is very, very apparent," Beckley said. "I didn't think it was going to be this huge in this community. As soon as we meet the goal, we hope to have the prototypes out there."
About a year into trying to start a family, Beckley began charting her cycles to better understand her body. But it was not working well. She used several methods of tracking ovulation, which left her with mixed results and an uncertainty that she had ovulated.
With her background in microbiology, Beckley focused on progesterone, a hormone present in a woman's body in the latter part of her cycle, called the luteal phase. A rise in progesterone is an indicator that ovulation has taken place.
During pregnancy, progesterone levels typically remain high to support the baby's development.
Looking at methods to chart fertility, Beckley thought: "Why can't I just test for progesterone?"
Conducting research, Beckley discovered little had been published on such testing.
After having her children, Beckley knew she wanted to help other women who were trying to conceive.
"I kept thinking back about how horrible I felt that I could not conceive a child," she said. "I kept coming back to the idea ... a lot of my friends I have met because of our troubles to conceive. This is such a big problem, and I felt like I have the power in me to make one of these."
Such a test would provide a way for a woman to confirm that ovulation has occurred and help a couple to achieve pregnancy or to avoid pregnancy.
Beckley originally pitched the idea to several infertility support groups, but did not get much response. However, Facebook NFP interest groups produced overwhelming response.
"It was just amazing," she said. "I did not realize what an interest there would be. I thought, how did we miss this?"
Depending on the contribution level through the crowd-funding campaign, supporters will receive a supply of tests, which Beckley said will be manufactured in a U.S. Food and Drug Administration-registered facility and will be federally approved. In turn, users will offer feedback, with the data to be used to hopefully reclassify the test as a diagnostic device according to FDA standards, Beckley said.
In April, Beckley e-mailed Dr. Richard Fehring, director of Marquette University's Institute for Natural Family Planning, about incorporating the test into the protocols used with the Marquette Method, one of several Church-approved methods of natural family planning. The method relies on the Clearblue Fertility Monitor, which measures hormone levels in urine to estimate the beginning and end of the time of fertility in a women's menstrual cycle. The method also can be used in conjunction with observing a woman's cervical mucus, basal body temperature and other biological markers.
Fehring and others have been discussing the use of an at-home urine test for progesterone for almost two decades. Most companies who manufacture tests and devices to help couples achieve pregnancy do not have an interest, because they don't see a market for it.
"They don't see that as helpful for trying to achieve (pregnancy)," Fehring said. "With the (progesterone) test, it's too late to achieve pregnancy" since it confirms ovulation after the fact.
The progesterone test fits with natural family planning because women monitor the entire cycle. Some physicians use quantitative blood serum tests in extreme cases to check progesterone, but that practice is not as convenient as an in-home test.
"It would be great for those who wish to confirm ovulation so they can be more at peace that they are in the post-ovulation infertile phase of the menstrual cycle," Fehring said.
Dr. Mary Lee Barron, a family nurse practitioner who leads Marquette Fertility Education in St. Louis, said the test, if it comes to fruition, will be a game-changer for NFP users.
"This has been badly needed for a long time," she said.
In the past dozen or so years, Marquette developers have been studying the effects of perimenopause and the transition of fertility from breast-feeding. Barron is conducting a study that analyses the effectiveness of using cheaper individual ovulation tests compared to the Clearblue Fertility Monitor.
"We have been looking for a progesterone (test), but none of the big companies are interested," she said. "We really want this for the couple who has confusing fertility signals, so they can determine if they've ovulated or not. This is a wonderful development, and hopefully all of the methods of natural family planning will benefit from it."