Many couples who are facing infertility find that there are few satisfying therapeutic options between timing ovulation and undergoing IVF. There is another lesser known category of treatment that couples can consider; cervical cap insemination. To use this technique, the semen is collected and placed into a small cap which is inserted into the vagina and onto the cervix, the opening to the uterus. The sperm are held next to the cervical mucus while being shielded from the vaginal environment. Without this protection the sperm die within minutes after intercourse. Capping the semen onto the cervix allows all the available sperm to swim up into the uterus and fallopian tubes, to where the egg will be. The cervical cap can be used for treating 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 medical literature since the first edition of Fertility and Sterility in 1950. At that time, Dr. M.J. Whitelaw wrote about a technique for insemination by “using 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 low sperm count. At the time, other OB/GYNs were also doing cervical cap insemination, but with a heavier cup made of surgical steel, with the women undergoing treatment having to lie down in the doctor’s exam room for six hours with their hips elevated.
Cervical cap insemination was used widely into the 1970’s and 1980’s. Effective for the treatment of low sperm count and tilted cervix, it was also used for unexplained infertility. In 1983, Dr. Michael Diamond and colleagues found that women with primary infertility, defined as no prior pregnancies, had a pregnancy rate of 43% in the first six months of cervical cap use. Women with secondary infertility, having a history of at least one pregnancy, had a pregnancy rate of 67% in the first six months of use. (2) Their method included a cervical cap that was placed by the patient onto the cervix then filled with semen using a catheter that fit into a small opening in the cap. The couples treated in this study generally had low sperm count and/or poor post coital test results, yet had normal evaluations of the female. The doctors in the study also offered cap insemination as an option for couples who had not completed a full evaluation which at the time 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 Invitro Fertilization (IVF) and subsequently Intra Cytoplasmic Sperm Injection (ICSI), cervical cap insemination began to fall by the wayside. During the economic boom of the 1990’s, with more discretionary income, couples had access to a multitude of tests and procedures, even if their insurance did not cover them. Such tests as Hamster Egg Penetration, Hypo Osmotic Swelling Test, and Antibody Testing which were popular a few years back are not as frequently ordered by doctors today, citing the value of the results obtained compared with the money spent. ICSI, which was developed to treat low sperm count, is now used a majority of the time by clinicians with IVF. 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 use of ICSI had increased five times although the sperm quality parameters over that same time period essentially remained the same.
While the cost and use of high tech treatments has skyrocketed in recent years, the cervical cap and at home insemination is quietly making a comeback. Couples interested in more cost effective, natural methods are seeking out other options for conceiving. At home insemination by cervical cap is a treatment option that can fit into several places in a couple’s fertility planning. For couples just beginning on their fertility journey, at home insemination could be used as a first step, especially when one or both of the partners are reluctant to spend a lot of time at the doctor’s office. For those who have been trying to conceive for several cycles, and may be taking fertility medications to enhance ovulation, a cervical cap could add another valuable tool to the treatment plan. Lastly, couples who are undergoing IVF cycles, or who have had IVF in the past, may want to try an at home insemination method on their cycles away from the more aggressive treatments. Single mothers of choice can also benefit from this technique as an alternate insemination delivery system.
Cervical caps, which have also been used for contraception 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 at home insemination is a modern upgrade of the old rigid plastic or metal caps of the past. The newer version is made of soft implantable grade silicone, and has flanges in the inner rim to create a one size cap that does not need to be custom fitted. It can be worn during normal activities, allowing a woman the freedom to go about her regular daily routine.
The clinical trial done for FDA clearance in 2007 was designed using couples who had been diagnosed with infertility; most of them also had attempted other methods such as IVF and IUI. The results were that 84% of patients found that placing the cervical cap on their cervix was easy to do, and 92% of patients found that the instructions were 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)
Cervical cap use has shown positive results in the past and has something significant to contribute to the future of reproductive medicine. With the cost of medical expenses rising beyond the ability of the average consumer to pay, at home cervical cap insemination may be an attractive option for continuing pursuing family building in tough economic times.
Footnotes
1. Whitelaw 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 following use of the cervical cup for home artificial insemination utilizing homologous semen. Fertility and Sterility. 1983 April; 39(4); 480-4.
3. Conception Kit clinical trials, Conceivex. 2006-2007