Many couples dealing with infertility find that there are few satisfactory treatment options between the time of ovulation and IVF. There is another, lesser-known category of treatment that couples can consider; cervical cap insemination. To use this technique, semen is collected and placed in a small cap that is inserted into the vagina and into the cervix, the opening of the uterus. The sperm are kept together with the cervical mucus while being protected from the vaginal environment. Without this protection, the spermatozoa die minutes after intercourse. Plugging the semen in the cervix allows all available sperm to swim to the uterus and fallopian tubes, where the egg will be. The cervical cap can be used to treat low sperm count, low sperm motility, tilted cervix, and other common conditions.

Cervical caps have been used by gynecologists and urologists for decades and have been documented in the medical literature since the first edition of Fertility and Sterility in 1950. At the time, Dr. MJ Whitelaw wrote of a technique for insemination using the ” use of a plastic cervical cap. filled with the husband’s semen applied to the cervix for 24 hours.” (1) This was done to treat oligospermia, which is a low sperm count. At the time, other OB/GYNs were also performing cervical cap inseminations , but with a heavier cup made of surgical steel, and women undergoing the treatment had to lie in the doctor’s exam room for six hours with their hips elevated.

Cervical cap insemination was widely used in the 1970s and 1980s. Effective for the treatment of low sperm count and sloping cervix, it was also used for unexplained infertility. In 1983, Dr. Michael Diamond and his colleagues found that women with primary infertility, defined as no previous pregnancy, had a 43% pregnancy rate in the first six months of cervical cap use. Women with secondary infertility, with a history of at least one pregnancy, had a 67% pregnancy rate in the first six months of use. (2) Her method included a cervical cap that the patient placed on the cervix and then filled it with semen using a catheter that fit into a small opening in the cap. Couples treated in this study generally had low sperm counts and/or poor results on postcoital tests, but had normal evaluations of the woman. The study physicians also offered cap insemination as an option for couples who had not completed a full evaluation that currently included diagnostic laparoscopy. This allowed patients to continue trying to conceive and use all of their cycles, while still considering advanced options.

Eventually, with the advent of In Vitro Fertilization (IVF) and later Intracytoplasmic Sperm Injection (ICSI), cervical cap insemination began to be forgotten. During the economic boom of the 1990s, with more discretionary income, couples had access to a multitude of tests and procedures, even if their insurance didn’t cover them. Tests such as the hamster egg penetration, hypo-osmotic swelling test, and antibody test, which were popular a few years ago, are not requested as often by doctors today, citing the value of the results obtained compared to the money spent. ICSI, which was developed to treat low sperm count, is now used most often by IVF doctors. In the most recent data collected, the Society for Assisted Reproductive Technology (SART) reports that ICSI use for 2006 was 62% of all IVF cycles. In 2007, a study published in the New England Journal of Medicine showed that over a decade, the rate of ICSI use had increased fivefold, although sperm quality parameters over the same period remained basically the same.

While the cost and use of high-tech treatments have skyrocketed in recent years, the cervical cap and home insemination are quietly making a comeback. Couples interested in more cost-effective natural methods are looking for other options to conceive. Home cervical cap insemination is a treatment option that can fit into a number of places in a couple’s fertility planning. For couples just beginning their fertility journey, home insemination could be used as a first step, especially when one or both partners are reluctant to spend a lot of time in the doctor’s office. For those who have been trying to conceive for several cycles and may be taking fertility drugs to enhance ovulation, a cervical cap could add another valuable tool to the treatment plan. Lastly, couples undergoing IVF cycles, or who have had IVF in the past, may want to try a home insemination method in their cycles away from the more aggressive treatments. Single mothers who choose may also benefit from this technique as an alternative insemination delivery system.

Cervical caps, which have also been used as contraceptives to prevent pregnancy, are part of the Code of Federal Regulations (CFR). The current term for cervical cap devices used for insemination is conception cap. The cervical cap currently available for home insemination is a modern update to the old rigid plastic or metal caps of the past. The newest version is made of soft, implantable-grade silicone and is ribbed on the inside edge to create a one-size-fits-all cap that doesn’t need a custom fit. It can be worn during normal activities, allowing a woman the freedom to go about her usual daily routine.

The clinical trial conducted for FDA clearance in 2007 was designed with couples diagnosed with infertility; most of them had also tried other methods such as IVF and IUI. Results were that 84% of patients found placing the cervical cap on the cervix easy to do, and 92% of patients found the instructions easy to understand. Of the patients involved in the clinical trial, 24% became pregnant within the first month, including couples with failed IVF and IUI attempts. (3)

The use of the cervical cap has shown positive results in the past and has something important to contribute to the future of reproductive medicine. With the cost of medical expenses rising beyond the ability of the average consumer to pay, home cervical cap insemination may be an attractive option to continue seeking to build a family in tough economic times.

Footnotes

1. White Law MJ. 1950. Use of the cervical cap to increase fertility in case of oligospermia. Fertility and Sterility. 1:33.

2. Diamond, MP, Christianson C. Daniell JF, Wentz AC. Pregnancy after the use of a cervical cup for home artificial insemination using homologous semen. Fertility and Sterility. 1983 April; 39(4); 480-4.

3. Design of Clinical Trials Kit, Conceivex. 2006-2007