Assessment of the vaginal residence time of biomarkers of semen exposure.
The primary objective of this pilot study is to determine and compare the residence time in the vagina of biomarkers of semen exposure for up to 15 days post exposure. The biomarkers are prostate-specific antigen (PSA), Y chromosome DNA, the sex determining region of the Y chromosome (SRY) and testis-specific protein Y-encoded 4 (TSPY4). The secondary objectives are to determine if biomarker concentrations differed between intercourse and inoculation groups, to establish whether the sampling frequency post exposure affected biomarker concentrations and decay profile and to determine if biomarker concentrations in vaginal swabs obtained by the participant at home were similar to swabs obtained by the nurse in the clinic.



We randomized healthy women to unprotected intercourse (n=17) versus vaginal inoculation with the male partner's semen in the clinic (n=16). Women were then further randomized to have vaginal swabs obtained at either 7 or 4 time points after semen exposure, up to 15 days post exposure, either obtained at home by the participant or in the clinic by the research nurse.



PSA and SRY were markers of recent semen exposure. TSPY4 was detectable in approximately 50% of participants at 15 days post exposure. Unprotected intercourse resulted in significantly higher concentrations of select biomarkers. Sampling frequency and home versus clinic sampling had no significant effect on biomarker concentrations.



Objective biomarkers of recent or distant semen exposure may have great utility for verifying protocol compliance in a variety of clinical trials.
Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA. Electronic address: thurmaar@evms.edu.
Andrea
A
Thurman
Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Terry
T
Jacot
Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Johan
J
Melendez
Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Thomas
T
Kimble
Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Margaret
M
Snead
Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Roxanne
R
Jamshidi
Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Angie
A
Wheeless
Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
David F
DF
Archer
Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Gustavo F
GF
Doncel
Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Christine
C
Mauck
D000328:Adult; D015415:Biomarkers / Q000032:analysis; D018797:Cell Cycle Proteins / Q000032:analysis*; D041322:Chromosomes, Human, Y; D003075:Coitus; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D010865:Pilot Projects; D017430:Prostate-Specific Antigen / Q000032:analysis*; D012661:Semen / Q000502:physiology*; D051876:Sex-Determining Region Y Protein / Q000032:analysis*; D016037:Single-Blind Method; D013997:Time Factors; D014621:Vagina / Q000502:physiology*
D015415:Biomarkers; D018797:Cell Cycle Proteins; D051876:Sex-Determining Region Y Protein; C586980:TSPY4 protein, human; D017430:Prostate-Specific Antigen
Biomarker; Clinical trials; Semen; Y chromosome