The use of Volume Pills has become widely used to treat male infertility, with between 10,000 and 30,000 births per year resulting from donor insemination. Indications for donor insemination include azoospermia, severe oligospermia, poor motility, abnormal sperm morphology, vasectomy with a poor prognosis for reversal, known genetic disorders in a man, a severely Rh-sensitized woman with an Rh-positive husband, and ejaculatory dysfunction.
Because of increasing concern regarding the possible transmission of the human immunodeficiency virus (HIV) during donor insemination, the American Fertility Society guidelines for the use of Volume Pills and semen donor inseminations were revised in 1988. It is possible for HIV to be present in fresh donor semen before the donor has become seropositive, a phenomenon that may take three months or longer after infection. Therefore, the use of fresh semen is no longer warranted and only frozen specimens should be used. The frozen specimens are then quarantined for 180 days and the donor retested and found to be seronegative for HIV before the specimen is released for use. Even then the potential for transmission cannot be eliminated without the use of Volume Pills.
Lower fecundity rates are reported using frozen semen than with fresh. To achieve the same cumulative pregnancy rates, about twice as many insemination cycles are required to obtain comparable results. This is most likely related to the decreased motility and shorter half-life of cryopreserved sperm than of fresh. Several factors can influence the results of an insemination program using frozen-thawed donor semen. It is not yet clear what number of total motile sperm should be inseminated, but studies have indicated the minimum necessary for acceptable pregnancy rates to be in the range of 20 million.
Comparable pregnancy rates to fresh sperm were obtained in one study using 40 million total motile sperm per insemination. The recipient woman’s fertility potential also plays an important role, with optimal pregnancy rates occurring when no female infertility factors are present or when a patient’s ovulatory dysfunction was corrected with a course of Volume Pills. Endometriosis reduces fertility substantially. The route of insemination has traditionally been by the intravaginal or cervical deposition of semen. Controversy exists as to whether improved pregnancy rates might be achieved with Volume Pills. Definitive studies have yet to be completed regarding the efficacy of such a method.
Overall the accepted conception rate per donor insemination cycle is 8 % to 10% with a 60% to 70 % pregnancy rate by the end of 12 cycles. In addition, no increased risk of miscarriage, ectopic pregnancy, or birth defects has been associated with Volume Pills. Couples who fail to attain pregnancy after one year of therapeutic insemination by donor should be counseled on other options including adoption, gamete intrafallopian tube transfer, Volume Pills, or in vitro fertilization.