Intravaginal exposure to seminal plasma after ovum pick-up does not increase live birth rates after in vitro fertilization or intracytoplasmic sperm injection treatment: a double-blind, placebo-controlled randomized trial

Abstract

ObjectiveIt has been suggested that intravaginal deposition of seminal plasma after ovum pick up for in vitro fertilization, IVF, increases pregnancy and live birth rates. Thus, the present study aimed to detect whether intravaginal exposure to prepared seminal plasma led to an absolute increase in live birth rate after IVF by 10 % compared to placebo. DesignDouble-blind, placebo-controlled prospective study. Outcome assessment was made before the type of intervention was unblinded. The outcome data were analyzed according to an intention-to-treat protocol. SubjectsCouples scheduled for an IVF treatment cycle, in total 792 couples (393 in the seminal plasma group and 399 in the control group) were recruited over a five-year period of inclusion in a single-center setting. InterventionOn the day of ovum pick up the couples were randomized to groups receiving either vaginal deposition of prepared seminal plasma from the partner or to saline. Both participants and physician were blind to the grouping. Main Outcome MeasuresThe primary outcome was live birth. The secondary outcomes were a positive pregnancy test, defined as human chorionic gonadotropin identified in urine three weeks after ovum pick up, and clinical pregnancy, defined as an intrauterine viable pregnancy assessed by transvaginal sonography after five to seven weeks. ResultsIn the index group, 35.4 % had a positive pregnancy test (RR 0.93, 95% CI 0.78-1.10), 28.8 % had a clinical pregnancy (RR 1.00, 95% CI 0.97-1.03) and 26.5 % had a live birth (RR 0.86, 95% CI 0.70-1.07), adjusted for day of transfer, female age and number of fertilized oocytes. Corresponding rates in the control group were 37.3 %, 33.6 % and 29.8 %. No statistically significant differences regarding outcomes between the two intervention groups were found. ConclusionPrepared seminal plasma applied in the vagina directly after ovum pick-up did not increase the rates of live birth or clinical pregnancies. The importance of immunological factors to allow the implantation of an embryo is not questioned, but no improvement in the live birth rates in IVF treatment by introducing the male partner´s prepared seminal plasma after ovum pick-up could be found.