Assessment of the vaginal residence time of biomarkers of semen exposure

Andrea Thurman, Terry Jacot, Johan Melendez, Thomas Kimble, Margaret Snead, Roxanne Jamshidi, Angie Wheeless, David F. Archer, Gustavo F. Doncel, Christine Mauck

Research output: Contribution to journalArticlepeer-review

Abstract

Objective 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. Study design 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. Results 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. Conclusions Objective biomarkers of recent or distant semen exposure may have great utility for verifying protocol compliance in a variety of clinical trials.

Original languageEnglish (US)
Pages (from-to)512-520
Number of pages9
JournalContraception
Volume94
Issue number5
DOIs
StatePublished - Nov 1 2016

Keywords

  • Biomarker
  • Clinical trials
  • Semen
  • Y chromosome

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

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