BLOOMFIELD HILLS, Mich. — Conceivex Inc. has rolled out a new at-home infertility treatment available by prescription through most pharmacies nationwide.

Called The Conception Kit, the Food and Drug Administration-approved solution addresses low sperm count, low sperm motility, a hostile vaginal environment and other common fertility issues encountered by couples, Conceivex said Thursday.

Described as a first-step treatment, The Conception Kit provides three boxes of a one-month supply. Each monthly supply includes eight ovulation predictors to target the day of ovulation; a semen collector called the Conception Cap, designed to have zero impact on the health of the sperm and the permeability of cervical mucus; a special lubricant that has no impact on sperm or cervical mucus permeability; a sterile cervical cap with tray; a pregnancy test; and a Practice Conception Cap.

In addition, each box comes with a manual, a conception journal and a conception wheel to help couples know when to time the use of the kit.

Conceivex said The Conception Kit is available for a $30 to $75 co-payment with a prescription at more than 65,000 U.S. pharmacies, including Walgreens, Rite Aid, Walmart and Target. About 60% of U.S. insured individuals already have reimbursable access to the kit through pharmacy benefit managers Express Scripts and CVS Caremark, among others, the company added.

“While there are more than 20 million women who are affected by infertility today, we also know that male sperm counts have declined 58% since 1938,” stated Michael La Vean, president and founder of Conceivex. “Clearly, millions of couples need some extra help to start their families — ideally assistance that is affordable, private, and doesn’t require extensive hormone and other invasive treatments.”

Conceivex noted that a Centers for Disease Control and Prevention (CDC) report released this month showed that U.S. fertility rates have fallen to an all-time low and are driven by a range factors, including the effect of more than a dozen over-the-counter medications.

According to the CDC, the number of babies born per 1,000 women ages 15 to 44 is at its lowest level since 1909. The report said the fertility rate fell from 60 births per 1,000 women in the first quarter of 2015 to 59.8 per 1,000 in the first quarter of 2016, indicating that fewer babies are being born to women of likely childbearing age. The general fertility rate in the United States has dropped more than 10% since 2007.

For men, OTC drugs that can decrease fertility include anabolic steroids and corticosteroids, high-blood pressure medications, diuretics, some common antacids, certain anti-inflammatory medicines, certain antipsychotics, methadone, anticonvulsants, chemotherapy and immunosuppressant medications.

The Conception Kit is an FDA cleared, drug- and hormone-free infertility first step treatment that couples use in the privacy of their own home. It is available nationally for a $30-$75 co-pay with a prescription at more than 65,000 pharmacies in the U.S., including Walmart, Target, Rite Aid, and Walgreens. Additionally, about 60 percent of insured individuals in the U.S. already have reimbursable access to it through their pharma benefits managers Express Scripts, CVS/Caremark, and others.

For approval of The Conception Kit, the FDA required clinical trials on the placement of the Conception Cap and instructions by patients, Conceivex said. During the trials, 24% of the patients became pregnant in the first 30 days, and this group had failed with other conception methods, such as in vitro fertilization and intrauterine insemination.

Patients who can successfully conceive using The Conception Kit have a likelihood of having a single, healthy birth at full term based on successful user accounts to date, according to Conceivex.

“The Conception Kit is an important step toward answering a wide range of infertility questions for American couples,” La Vean added. “I encourage people who may be struggling to conceive to look into all possible options and discuss the best route to fulfill your family goals with your doctor.”