Evidence map›Paper›PMID 27259675›Full record

Trial reportContraception2016

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

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Contraception, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Semen: A modulator of female genital tract inflammation and a vector for HIV-1 transmission.American journal of reproductive immunology (New York, N.Y. : 1989) · 2021
    Review
  5. Article
  6. Article
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Observational
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Andrea ThurmanEastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA. Electronic address: thurmaar@evms.edu.
Terry JacotEastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Johan MelendezEastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Thomas KimbleEastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Margaret SneadEastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Roxanne JamshidiEastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Angie WheelessEastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
David F ArcherEastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Gustavo F DoncelEastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.
Christine MauckEastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

objectiveThe 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

designWe 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.

resultsPSA 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.

conclusionsObjective biomarkers of recent or distant semen exposure may have great utility for verifying protocol compliance in a variety of clinical trials.

Indexed as

AdultBiomarkersCell Cycle ProteinsChromosomes, Human, YCoitusFemaleHealthy VolunteersHumansMalePilot ProjectsProstate-Specific AntigenSemenSex-Determining Region Y ProteinSingle-Blind MethodTime FactorsVaginaBiomarkersCell Cycle ProteinsProstate-Specific AntigenSex-Determining Region Y ProteinTSPY4 protein, humanBiomarkerClinical trialsSemenY chromosome

Identifiers

PMID27259675
PMCPMC5075505

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.