Efficacy of the Female Condom as a Barrier to Semen During Intercourse

Macaluso, Maurizio; Lawson, M. Louise; Hortin, Glen L.; Duerr, Ann; Hammond, Karen R.; Blackwell, Richard E.; Bloom, Amy

doi:10.1093/aje/kwf212

Cited by 70 publications

(39 citation statements)

References 11 publications

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“…Thus, if the last exposure was to a large amount of semen, it is possible that the pre-coital and post-coital swabs will vary by up to 22 ng/mL by chance alone. This criterion was used in evaluating semen exposure in some studies [6,10], while other studies employed a 15 ng/mL difference [9,11]. Changing the minimum difference from 22 to 15 ng/mL would change the probability of a false-positive exposure assessment by a small amount.…”

Section: Resultsmentioning

confidence: 99%

“…Because all results evaluated were far from the predefined threshold for defining exposure (>22 ng/mL increase in post-coital PSA), misclassification of exposure is unlikely to have occurred. While this study was not designed to meet biological thresholds for conception or sexually transmitted infection (STI), it is important to note that processed semen samples containing fewer than 10×10 6 spermatozoa are unlikely to result in fertilization [17]. Since the median sperm count in fertile men ranges between 70×10 6 /mL and 100×10 6 /mL [18,19], exposure to a volume of ejaculate <0.1 mL is not likely to result in conception.…”

Section: Discussionmentioning

confidence: 99%

“…Objective biomarkers of semen exposure, most notably prostate-specific antigen (PSA), are valid predictors of exposure to semen and may offer a reliable counterpart to user self-report for assessing condom performance during penile-vaginal intercourse [1]. An increasing number of clinical trials have incorporated testing for PSA levels to assess the performance of male and female condoms [2][3][4][5][6][7][8][9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

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Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance

et al. 2012

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Background-Prostate-specific antigen (PSA), a biomarker for semen exposure, may provide a more objective measure of condom failure than subject self-reports. Methods for measuring PSA vary and their comparability with respect to assessing condom performance has not been adequately evaluated. This study compared results from three different PSA assays of vaginal samples collected by subjects in a randomized clinical trial which compared the performance of female condoms.Study Design-We selected 30 pairs of pre-and post-coital vaginal samples from subjects who reported condom functionality problems or whose original PSA assay was positive. Samples were retested using three different PSA assays [quantitative enzyme-linked immunoassay (EIA), rocket immune-electrophoresis (RIE) and chromatographic immunoassay (CIA)]. We compared the proportion of condom uses where the post-coital PSA result indicated semen exposure for each of the three assays.Results-Despite varying levels of sensitivity, the results from all three assays were remarkably consistent. Self-reported condom failures did not correlate well with positive PSA results, suggesting that exclusive reliance on either PSA or user self-report may be inadequate for assessing condom functionality. HHS Public Access Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptConclusion-In combination with user self-report of condom failure, PSA testing provides a reliable, objective marker of condom functionality. Studies based on PSA testing may improve on conventional contraceptive clinical trials by offering a more direct assessment of a condom product's ability to prevent semen exposure.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance

et al. 2012

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“…[64][65][66][67][68] PSA tests detect relatively small amounts of semen, and, given the unknown infectious dose of the STI and HIV organisms, the consequences of these exposures to semen is unknown. Interpreting the public health significance of PSA levels requires additional research on what level of PSA exposure in semen is meaningful for disease transmission, and, given natural variation of PSA concentration in semen, what level of semen exposure indicates method failure.…”

Section: Methodological Controversies In Study Designmentioning

confidence: 99%

Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions

Minnis

Padian²

2005

Sexually Transmitted Infections

101

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Objectives: To evaluate evidence for the effectiveness of female controlled physical and chemical barrier methods in preventing STI/HIV transmission, to examine recent reviews on microbicide development, and to highlight promising research directions. To discuss challenges in conducting effectiveness research and in translating results to public health intervention. Methods: Systematic review of articles that examined the disease prevention effectiveness of at least one female controlled barrier method. Review of conference abstracts that presented clinical and preclinical microbicide data. Results: Randomised controlled trials provide evidence that female condoms confer as much protection from STIs as male condoms. Observational studies suggest that the diaphragm protects against STI pathogens. Several microbicide effectiveness studies are under way and new directions, such as adaptation of therapeutic agents as preventive products, are being examined. Substantial attention is now given to product formulation and novel delivery strategies. Combining microbicide products with different mechanisms of action as well as combining chemical and physical barriers will be necessary to maximise prevention effectiveness. Conclusions: Increased investment in the development and identification of female controlled barrier methods offers promise that additional products will be available in the years ahead. Generalising trial results to a community setting, promoting products that may be less effective than male condoms, and bringing an effective product to scale introduce public health challenges that warrant attention. The need for female controlled barrier methods that provide women with the opportunity to take an active role in reducing their STI/HIV risk are urgently needed and constitute an essential tool to prevent continued spread of these infections.

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“…The PSA concentration in semen is about 10 million times greater than that in serum, 13 which renders PSA a highly sensitive marker for seminal plasma in studies of condom failure [14][15][16][17][18][19] or forensic investigation of sexual assault. [20][21][22] So far, studies of urinary PSA have mainly focused on their applications in detection of prostatic pathology.…”

Section: Introductionmentioning

confidence: 99%

Objective non-intrusive markers of sperm production and sexual activity

Sivananthan¹,

Bathur²,

Jiménez³

et al. 2012

Asian J Androl

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Objective studies of men's reproductive function are hindered by their reliance on: (i) self-reporting to quantify sexual activity and (ii) masturbation to quantify sperm output rendering both types of estimate vulnerable to unverifiable subjective factors. We therefore examined whether detection of spermatozoa and measurement of prostate-specific antigen (PSA) in urine could provide objective semiquantitative estimates of sperm output and recent ejaculation, respectively, using widely available laboratory techniques. Of 11 healthy volunteers who provided urine samples before and at intervals for 5 days after ejaculation, sperm was present in 2/11 men before, and in all 11/11 samples immediately after ejaculation, but by the second and subsequent void, spermatozoa were present in ,10%. PSA was detectable at high levels in all urine samples, peaking at the first post-ejaculatory sample but returning to baseline levels by the second post-ejaculatory void. We conclude that urinary spermatozoa and PSA are objective biomarkers for sperm production and sexual activity, but only for a short-time window until the first post-ejaculatory urine void. Hence, for a single urine specimen, the presence of spermatozoa and PSA are valid biomarkers, reflecting sperm production and recent ejaculation only until the next micturition, so their measurement should be restricted to the first morning urine void. Keywords: ejaculation; PSA; sexual activity; sperm output; spermatozoa; urine INTRODUCTIONMajor limitations for objective studies of human male reproductive function are the reliance on self-reporting of sexual activity and on masturbation to provide semen samples for analysis of sperm output. Both intrude on sensitive personal matters and rely wholly or partly on subjective aspects of sexual activity. Self-reporting of sexual activity is influenced by complex personal attitudes and perceptions and is effectively impossible to corroborate. Hence, such data are subject to unverifiable bias or distortion. Similarly, the only objective measure of sperm output requires semen specimen collected by masturbation, usually a sensitive and private activity. As a result, men are reluctant to participate in studies requiring semen samples unless actively concerned about their fertility, creating a major participation bias.

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Efficacy of the Female Condom as a Barrier to Semen During Intercourse

Cited by 70 publications

References 11 publications

Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance

Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance

Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions

Objective non-intrusive markers of sperm production and sexual activity

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