Cervical cap insemination is not a new treatment however using cervical cap insemination in the privacy of home is a new indication for this treatment with the FDA 510k clearance the Conception Kit®​.

The use of cervical cap insemination has been documented in medical literature for over a half century. The first article was by Whitelaw in the very first edition of Fertility and Sterility in 1950.

Available clinical data, studies, empirical evidence and logical analysis points to the conclusion that cervical cap insemination presents a legitimate and potentially preferable treatment option for some patients.

The question is not whether cervical cap insemination works but what are the appropriate medical indications for being initial treatment option?

Low sperm count or motility, acidic vaginal environment and the position of the cervix (since the cervical cap is placed over the cervix it addressed the position relative to the semen pool) represent infertility factors which can potentially be over or partially mitigated by direct semen exposure with cervical cap insemination.

The following studies have been done on cervical cap insemination:

References

Whitelaw, W J. Use of cervical cap to increase fertility in cases of oligospermia. Fertil Steril; 1950; 1:33.

Khan KS, et. al. Empirical evidence of bias in infertility research: overestimation of treatment effect in crossover trials using pregnancy as the outcome measure. Fertil Steril 65:.939ï45, 1965.

Scott, JZ. et. al., The cervical factor in infertility: diagnosis and treatment. Fertil Steril 1977; 28: 1289ï94.

Bergquist, CA, et. al, Artificial insemination with fresh donor semen using the cervical cap technique: a review of 278 cases. Obstet Gyn 1982, 60: 195-99.

Subak,, LL, et. al. Therapeutic donor insemination: a prospective randomized trial of fresh versus frozen sperm. Am J Obstet Gyn 1992; 166: 1957-1606.

Williams, DB, et. al. Does intrauterine insemination offer an advantage to cervical cap insemination in a donor insemination program? Fertil Steril 1995: 63:295-8.

Adamson, GD, et. al, Failure of intrauterine insemination in a refractory infertility population. Fertil Steril 1991; 56:361-3.

Whitelaw, WJ, The cervical cap self-applied in the treatment of serve oligospermia. Fertil Steril 1979; 31 :86-7.

Diamond, MP, et. a!., Pregnancy following use of the cervical cup for home artificial insemination utilizing homologous semen. Fertil Steril 183; 39:480.

Corson, SL, et. al., The cervical cap for home artificial insemination. Journal Reprod Med, 1986; 31:345ï52.

Mahony, MC. Evaluation of the effect of a cervical cap device on sperm function characteristics in vitro. Andrologia 2001; 33:207-13.

Hanson, FW, Overstreet, JW. The interaction of human spermatozoa with cervical mucus in vivo. Am. J Obstet Gyn 1981; 140:173-78. “It should be emphasized that the cervical cup technique is a very efficient system for delivery of spermatozoa to the cervix.’ (at 176).

Meyer, WR. et. al. Therapeutic cup insemination with cryopreserved donor sperm: prognostic value of cervical mucus score at insemination and the number of motile sperm in mucus at 24 hours. Fertil Steril 1996; 66:435-9.

Botchan, A, et. aI., Results of 6139 artificial insemination cycles with donor spermatozoa.Human Reprod 2001; 16:2298-2304.

Coulson, C. Randomized controlled trial of cervical cap with interacervical reservoir versus standard intracervical injection to inseminate cryopreserved donor semen. Human Reprod 1996; 11:84-87.

Flierman, PA, et. al. Prospective, randomized, cross-over comparison of two methods of artificial insemination by donor on the incidence of conception: intracervical insemination by straw versus cervical cap. Human Reprod 1997; 12: 1945-8.