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Journal ArticleDOI

2016 Laboratory guidelines for postvasectomy semen analysis: Association of Biomedical Andrologists, the British Andrology Society and the British Association of Urological Surgeons

15 Apr 2016-Journal of Clinical Pathology (BMJ Publishing Group)-Vol. 69, Iss: 7, pp 655-660

TL;DR: These 2016 guidelines replace the 2002 British Andrology Society laboratory guidelines and should be regarded as definitive for the UK in the provision of a quality PVSA service, accredited to ISO 15189:2012, as overseen by the United Kingdom Accreditation Service (UKAS).

AbstractPost-vasectomy semen analysis (PVSA) is the procedure used to establish whether sperm are present in the semen following a vasectomy. PVSA is presently carried out by a wide variety of individuals, ranging from doctors and nurses in general practitioner (GP) surgeries to specialist scientists in andrology laboratories, with highly variable results.Key recommendations are that: (1) PVSA should take place a minimum of 12 weeks after surgery and after a minimum of 20 ejaculations. (2) Laboratories should routinely examine samples within 4 h of production if assessing for the presence of sperm. If non-motile sperm are observed, further samples must be examined within 1 h of production. (3) Assessment of a single sample is acceptable to confirm vasectomy success if all recommendations and laboratory methodology are met and no sperm are observed. Clearance can then be given. (4) The level for special clearance should be <100 000/mL non-motile sperm. Special clearance cannot be provided if any motile sperm are observed and should only be given after assessment of two samples in full accordance with the methods contained within these guidelines. Surgeons are responsible both preoperatively and postoperatively for the counselling of patients and their partners regarding complications and the possibility of late recanalisation after clearance. These 2016 guidelines replace the 2002 British Andrology Society (BAS) laboratory guidelines and should be regarded as definitive for the UK in the provision of a quality PVSA service, accredited to ISO 15189:2012, as overseen by the United Kingdom Accreditation Service (UKAS).

Topics: Vasectomy (52%), Semen analysis (51%)

Summary (4 min read)

INTRODUCTION

  • Post vasectomy semen analysis (PVSA) is the laboratory procedure used to establish whether sperm are present in the semen following a vasectomy.
  • This ranges from doctors and nurses in GP surgeries to specialist scientists in dedicated andrology laboratories.
  • In 2002 the British Andrology Society (BAS) published a set of laboratory guidelines for PVSA [1].
  • Revisions include clarifying factors around when and how to test and the number of samples that should be examined.
  • Measurements of vasectomy failure are complex to interpret, as many are only discovered after an adverse outcome, i.e. occurrence of a pregnancy.

FERTILITY OF RESIDUAL SPERM POST SURGERY

  • Ejaculates may contain potentially fertile sperm immediately after vasectomy [15], and patients should continue with contraceptive precautions until successful vasectomy has been confirmed.
  • This has been extensively discussed in the 2002 BAS guidelines [1] and by the FSRH [2].

Scheduling of sample testing

  • The time between the vasectomy and the PVSA has been widely discussed without agreement, with some publications even suggesting a wait of up to 6 months before first analysis [16].
  • This may be due to an inflammatory reaction and/or temporary bruising within the testis.
  • Testing too early may also cause problems with analysis due to high sample viscosity, presence of residual (usually non-motile) sperm and raised levels of round cells that may mask sperm presence.
  • Therefore, the desire to perform prematurely early PVSAs has to be balanced against the increased patient inconvenience and also the workload / cost to the laboratory (e.g. [16 17 22 23]) as repeat tests would be required for accurate confirmatory diagnosis.
  • It has also been reported that azoospermia may not be achieved until 60 ejaculates for some individuals [25].

Pre-Assessment

  • The laboratory staff should ensure that the person requesting the PVSA test is provided with clear ‘user information’ in the form of written instructions for sample collection.
  • Sample production should be arranged on an appointment basis to ensure the laboratory has sufficient time for each assessment to be completed within recommended analytical time frames.

The specimen container

  • Gamma-irradiated and mouse embryo assay (MEA)-tested specimen containers are recommended for use, together with CE-marking for containers manufactured in Europe.
  • None of these tests confirm the level of sperm non-toxicity.
  • Specimen containers should therefore additionally be confirmed as non-toxic to sperm via an in-house sperm toxicity bioassay [26].
  • If samples are provided in unscreened specimen containers, the PVSA report will only be valid if no sperm are observed.
  • If sperm are observed, and they are immotile, then no confirmation of sperm non-toxicity from the 2016 PVSA Guidelines specimen container can be provided.

Instructions to patients

  • Patients should be advised to produce a sample in accordance with guidelines for good practice e.g. [27] 29.
  • The abstinence period should be between 2 and 7 days as per the latest WHO guidance [28].
  • Men should be asked to collect their entire ejaculate by masturbation.
  • Use of coitus interruptus, condoms or oral production is not recommended as this can lead to sample contamination.
  • One study reported that 9.4% PVSA samples were not completely collected [29], which could increase the risk of misdiagnosis if analysed.

Receipt of Samples

  • On delivery of the semen sample to the laboratory reception, staff should ensure that the specimen container is clearly labelled with at least three patient identifiers (e.g. name, date of birth, and clinic number) and that details of sample collection are recorded, e.g. abstinence period and confirmation that the entire sample was collected.
  • All staff dealing with patient contact should be trained appropriately in respecting privacy and dignity.
  • Associated facilities and systems for the service should also ensure that this is recognised as an important part of diagnostic provision.

Overall Guidance on Sample Procurement

  • To prevent time delays or fluctuations in temperature, on-site production facilities are recommended.
  • If non-motile sperm are observed, further samples must be examined within 1 hour of production.
  • If samples are over 4 hours old as stated above, there is currently insufficient data to validate the accuracy of any results obtained, particularly with relation to uncontrolled transport situations.
  • Laboratories accepting posted/couriered samples should ensure that patients understand the sample/request form labelling requirements and the current regulations for the transport and packaging of samples[32].
  • Where examination of a sample occurs outside recommended parameters this must be clearly noted on the report and clearance should not be given, also known as Recommendation 2b.

Sample examination

  • Samples should ideally be examined once liquefaction is complete, accepting that this may not be possible, since PVSA samples may continue to be highly viscous.
  • Two methods of examination are possible: 1. The original 2002 BAS guidelines method.
  • The entire pellet should be resuspended in a minimum volume of autologous seminal plasma (< 100μl) and the entire sample examined systematically for the presence of motile and non-motile sperm.
  • Microscopic examination of uncentrifuged specimens has been shown to be a reliable method for PVSA, provided >100,000 sperm per ml are present [37].
  • If the 100µm large volume fixed depth slide method is not used, it is the consensus view of the Professional Bodies that samples should be centrifuged.

INTERNAL QUALITY CONTROL

  • In order to ensure precise and accurate results from the PVSA testing laboratory, a process of internal quality control (IQC) is required.
  • Day-to-day monitoring of precision and accuracy reassures users of the service that there is uniformity within the laboratory.
  • IQC requires a central reference sample to enable direct comparisons between different laboratory staff performing PVSA.
  • An EQA scheme for PVSA should provide independent consensus for the presence/absence of sperm.
  • The impracticality of providing such EQA, which should involve sending out sperm-free samples and samples with a very low numbers of sperm, has deterred other schemes being set-up nationally or internationally to date.

POST ASSESSMENT - THE UNCERTAINTY FACTOR

  • There are many areas where uncertainty can lead to questions about the robustness of PVSA.
  • The recommendations in these guidelines aim to reduce the uncertainty.
  • Unless strict sample rejection criteria are enforced, a higher than necessary uncertainty will impact on the PVSA.
  • It has been reported that a large proportion of patients (up to 25%) fail to comply with instructions regarding sample collection, making reliable laboratory assessment impossible, or fail to submit a sample in the first place[16 39 40].
  • Such volumes should be included and highlighted in the final report to draw attention to this possible uncertainty.

HOW MANY SAMPLES SHOULD BE ASSESSED?

  • The 2002 BAS guidelines recommended examination of two samples per patient to ensure correct evaluation[1].
  • After assessing the supporting evidence, the Professional Bodies agree that assessment of a single sample is appropriate provided there is strict adherence to instructions for production, delivery and time to examination, to minimise any adverse effects on the sample.
  • Similarly, sperm have been reported to temporarily reappear in ejaculates 12 months after surgery, despite previous sperm-free ejaculates[9].
  • Discussion in the literature has suggested that the risk of pregnancy occurring from men whose previous samples show non-motile sperm present is small[39] and probably no more than the risk of pregnancy after two azoospermic semen samples, as a result of spontaneous recanalisation [3 45].
  • Laboratories must be able to validate & verify that their reported counts are accurate and what their detection accuracy or range may be, accepting there will be a measure of uncertainty.

CONCLUSIONS & IMPLEMENTATION

  • The Professional Bodies expect that implementation of these guidelines can occur from the date of publication and should be completed within 12 months.
  • The first semen analysis after vasectomy: timing and definition of success.
  • Tomlinson MJ, Harbottle SJ, Woodward BJ, Lindsay KS, Association of Biomedical A. Association of biomedical andrologists - laboratory andrology guidelines for good practice version 3 - 2012.

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University of Birmingham
2016 Laboratory guidelines for postvasectomy
semen analysis: Association of Biomedical
Andrologists, the British Andrology Society and the
British Association of Urological Surgeons
Hancock, Paul; Woodward, Bryan; Muneer, Asif; Kirkman-Brown, Jackson
DOI:
10.1136/jclinpath-2016-203731
License:
None: All rights reserved
Document Version
Peer reviewed version
Citation for published version (Harvard):
Hancock, P, Woodward, B, Muneer, A & Kirkman-Brown, J 2016, '2016 Laboratory guidelines for postvasectomy
semen analysis: Association of Biomedical Andrologists, the British Andrology Society and the British
Association of Urological Surgeons', Journal of Clinical Pathology. https://doi.org/10.1136/jclinpath-2016-203731
Link to publication on Research at Birmingham portal
Publisher Rights Statement:
Final version of record published as above and available at: http://dx.doi.org/10.1136/jclinpath-2016-203731
Checked April 2016
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Download date: 09. Aug. 2022

2016 Laboratory Guidelines for Post Vasectomy Semen
Analysis - Association of Biomedical Andrologists, the British
Andrology Society, and the British Association of Urological
Surgeons.
P Hancock
1
; BJ Woodward
1,4
; A Muneer
2,3,5
; JC Kirkman-Brown
2,6,7
1
Member of Association of Biomedical Andrologists (ABA) Executive committee
2
Member of British Andrology Society (BAS) Executive committee
3
Chairman British Association of Urological Surgeons (BAUS) Section Andrology
4
IVF Consultancy Services, Leicester, UK
5
Department of Andrology and Urology, University College London Hospitals, London, UK
6
Centre for Human Reproductive Science, Institute of Metabolic & Systems Research (IMSR), College of
Medical & Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK
7
Birmingham Women’s Fertility Centre, Birmingham Women’s NHS Foundation Trust, Birmingham, UK.
Abstract
Post vasectomy semen analysis (PVSA) is the procedure used to establish whether sperm are present in the
semen following a vasectomy. PVSA is presently carried out by a wide variety of individuals, ranging from
doctors and nurses in General Practitioner (GP) surgeries to specialist scientists in andrology laboratories, with
highly variable results.
Key recommendations are that: 1) PVSA should take place a minimum of 12 weeks after surgery and after a
minimum of 20 ejaculations; 2) Laboratories should routinely examine samples within 4 hours of production if
assessing for presence of sperm. If non-motile sperm are observed, further samples must be examined within
1 hour of production; 3) Assessment of a single sample is acceptable to confirm vasectomy success if all
recommendations and laboratory methodology are met and no sperm are observed. Clearance can then be
given; 4) The level for special clearance should be <100,000/ml non-motile sperm. Special clearance cannot be
provided if any motile sperm are observed and should only be given after assessment of two samples in full
accordance with methods contained within these guidelines.
Surgeons are responsible both pre-operatively and post-operatively for the counselling of patients and their
partners regarding complications and the possibility of late recanalisation after clearance.
These 2016 guidelines replaces the 2002 British Andrology Society (BAS) laboratory guidelines and should be
regarded as definitive for the UK in the provision of a quality PVSA service, accredited to ISO 15189:2012, as
overseen by the United Kingdom Accreditation Service (UKAS).
KEYWORDS
Guidelines, sterilisation, male, laboratory, protocols, spermatozoa, vasectomy
2016 PVSA Guidelines

2016 PVSA Guidelines

INTRODUCTION
Post vasectomy semen analysis (PVSA) is the laboratory procedure used to establish whether sperm are
present in the semen following a vasectomy. As such, PVSA indicates whether surgery has been successful to
achieve male sterilisation.
PVSA continues to be carried out by a wide variety of individuals with different levels of training. This ranges
from doctors and nurses in GP surgeries to specialist scientists in dedicated andrology laboratories. PVSA may
also be performed in general pathology laboratories. Consequently, the test quality and control of the
procedure is variable, which is clearly not acceptable for a Yes/Noindicator of surgical success.
In the UK, the move towards laboratory accreditation overseen by the United Kingdom Accreditation Service
(UKAS) to the international standard ISO 15189:2012, is driving the quality of the PVSA process forward. Only
laboratories meeting this analytical standard should be considered as providing the necessary reliability of
result to confirm successful vasectomy.
In 2002 the British Andrology Society (BAS) published a set of laboratory guidelines for PVSA [1]. Advances in
technique options, observations of areas where uncertainty exists and compliance with the ISO 15189:2012
standard, now make additions to the 2002 BAS guidelines desirable. Revisions include clarifying factors around
when and how to test and the number of samples that should be examined.
These 2016 guidelines have been agreed and accepted across the three major groupings and co-author
professional bodies for the field as best practice providing for standardisation of seminal analysis protocols
and reporting of results. Crucially it should be noted that they are not only clinical recommendations but also
take into account good laboratory practice and the accuracy of diagnosis. As such they supercede any prior
guidelines published for the UK. The guidelines do not deal with the counselling of patients or discuss the
indications for male sterilisation, for which compliance with the Faculty of Sexual & Reproductive Healthcare
(FSRH) clinical guidance for male and female sterilization is recommended[2].
It is always important for patients to be warned that a vasectomy may apparently fail at any time, though the
actual chance of this is rare, at less than 1% if correctly performed [3-8], with some reports suggesting that
temporary reappearance of sperm may occur a year after clear PVSA [9].
Failures can be classed into early and late recanalisation. Recanalisation is considered to have occurred where,
after an initial azoospermic sample, there is a rapid increase in sperm numbers [10 11] . These are suggested
to comprise the major category of vasectomy failures [12]. The potential for late recanalisation has been
reported to be around 0.04% to 1% [4 13].
Measurements of vasectomy failure are complex to interpret, as many are only discovered after an adverse
outcome, i.e. occurrence of a pregnancy. It should also be recognized that no data exist relating to women
who may seek pregnancy terminations after this unexpected outcome, perhaps without telling their partner.
As pregnancies have been confirmed to occur even after repeated azoospermic samples, [14] due caution
around the meaning of a PVSA result should always be noted in reports. The patient should be provided with
information from his clinician regarding the likelihood of a successful vasectomy operation and the possibility
of recanalisation. It is recommended that such information should be given both verbally and in writing [12].
FERTILITY OF RESIDUAL SPERM POST SURGERY
Ejaculates may contain potentially fertile sperm immediately after vasectomy [15], and patients should
continue with contraceptive precautions until successful vasectomy has been confirmed. This has been
extensively discussed in the 2002 BAS guidelines [1] and by the FSRH [2].
2016 PVSA Guidelines

POST VASECTOMY SEMEN SAMPLES
Scheduling of sample testing
The time between the vasectomy and the PVSA has been widely discussed without agreement, with some
publications even suggesting a wait of up to 6 months before first analysis [16]. However, the majority of
published literature suggests a minimum number of weeks before testing of between 12 [6 11 16 17], 14 [18
19] and 16 weeks [1 20]. Decreased patient compliance has been noted with longer intervals [6 17 20].
The earlier the PVSA testing occurs, the more the likelihood increases of a false positive result. This may be
due to an inflammatory reaction and/or temporary bruising within the testis. These is also evidence that early
recanalisation can occur within the first few weeks following a vasectomy, and this may be more common
after certain techniques[12] and may be transient [21]. Testing too early may also cause problems with
analysis due to high sample viscosity, presence of residual (usually non-motile) sperm and raised levels of
round cells that may mask sperm presence. Therefore, the desire to perform prematurely early PVSAs has to
be balanced against the increased patient inconvenience and also the workload / cost to the laboratory (e.g.
[16 17 22 23]) as repeat tests would be required for accurate confirmatory diagnosis.
There is a consensus that ‘sufficient ejaculations’ should take place between the vasectomy and the PVSA,
since ejaculatory frequency will affect time to azoospermia. [1 11 24]. Men with fewer than 3 ejaculations per
week have been reported to reach azoospermia around 5 weeks later than those with a higher number of
ejaculations [25]. It has also been reported that azoospermia may not be achieved until 60 ejaculates for some
individuals [25]. However, systematic review data indicates that by 20 ejaculates, 80% of men should show
azoospermia or sperm numbers beneath detectable levels [11] . It is therefore recommended that knowing
the number of ejaculates is important, though some authors have debated this point [24].
The recommendation is Grade B due to robust evidence, noting that it is surprising and disappointing that no
conclusive multi-centre study has yet occurred for such a prevalent procedure.
Recommendation 1: PVSA should take place a minimum of 12 weeks after surgery and after a minimum of
20 ejaculations.
Pre-Assessment
Sample collection instructions
The laboratory staff should ensure that the person requesting the PVSA test is provided with clear user
information’ in the form of written instructions for sample collection. Sample production should be arranged
on an appointment basis to ensure the laboratory has sufficient time for each assessment to be completed
within recommended analytical time frames.
The specimen container
Gamma-irradiated and mouse embryo assay (MEA)-tested specimen containers are recommended for use,
together with CE-marking for containers manufactured in Europe. However, none of these tests confirm the
level of sperm non-toxicity. Specimen containers should therefore additionally be confirmed as non-toxic to
sperm via an in-house sperm toxicity bioassay [26]. Confirmation of sperm non-toxicity should also apply to all
consumables used in the PVSA process that come in to contact with the sample, e.g. any tubes, slides,
coverslips and pipette tips. Traceable sperm toxicity testing is required for each new batch and make of item,
in accordance with ISO 15189:2012.
If samples are provided in unscreened specimen containers, the PVSA report will only be valid if no sperm are
observed. If sperm are observed, and they are immotile, then no confirmation of sperm non-toxicity from the
2016 PVSA Guidelines

Citations
More filters

Journal ArticleDOI
TL;DR: This guideline is aimed at health care scientists who deal with andrology in both general pathology and specialised fertility laboratories, and provides a model approach to sperm toxicity testing.
Abstract: In order to ensure the quality and integrity of diagnostic semen analysis results, materials used should be tested to ensure that they do not interfere with sperm function. As a toxicity test, complex sperm function testing may be considered controversial, since the fertilizing capacity of single sperm can never be assured. In preference, sperm motility offers a unique means of assessing the toxicity of reagents and materials before they are used in routine practice. Motility is the semen parameter most likely to be influenced by the external environment. Indeed, it is the main reason that laboratories insist on supplying their own approved specimen containers and ensuring that patients, as far as possible, adhere to strict conditions for sample collection and transport prior to testing. This differs to other indirect tests of toxicity such as the mouse embryo assay, whereby the rate of mouse pre-implantation embryo development to the blastocyst stage is compared. This guideline is aimed at health care scientists who deal with andrology in both general pathology and specialised fertility laboratories, and provides a model approach to sperm toxicity testing. For assisted reproduction clinics, the same methodology can be used to test any consumables that are used for sperm processing, and as an indirect guide for any consumables that come into direct contact with oocytes and pre-implantation embryos.

3 citations


Cites background from "2016 Laboratory guidelines for post..."

  • ...The MEL should not exceed 4-h, since this represents the maximum recommended delivery time that may be used for a post vasectomy sample [13]....

    [...]


Journal ArticleDOI
TL;DR: The prevalence of congenital unilateral absence of vas deferens in a cohort of 23,013 men presenting for vasectomy over a 20-year period in Quebec City, Canada and the importance of surgical planning in difficult vasectomy cases is reported is given.
Abstract: The vas deferens derives from the Wolffian (mesonephric) duct and shares a common origin with the kidney (1). Intrinsic Wolffian duct defects may result in failure of the vas deferens to develop, a condition that can occur in isolation or combined with renal agenesis or malformations. A missing vas, that is, unilateral absence of vas deferens, albeit relatively uncommon may be found by urologists performing vasectomies or evaluating men with fertility problems (1, 2). It is, therefore, important that urologists be aware of the practical implications when finding such a case scenario. In this issue of the International Braz J Urol, Miller and colleagues give us useful guidance by reporting the prevalence of congenital unilateral absence of vas deferens in a cohort of 23,013 men presenting for vasectomy over a 20-year period in Quebec City, Canada (3). Among the confirmed cases, namely, those with i. No prior genital surgery or trauma and ii. A missing vas at the time of vasectomy, and iii. Confirmed sterility by a post-vasectomy semen analysis (PVSA) after unilateral vasectomy, a missing vas was found once in every 479 men subjected to vasectomy. In their study, most vasectomies had been performed using a non-scalpel technique combining thermal cautery and fascial interposition (4), which has shown to be as effective as ligation and fascial interposition (5). To our knowledge, the paper by Miller et al. is the largest series reported to date thus making it sound to assume that most urologists performing vasectomies will find such a case in their career. Interestingly, the authors identified a group of 34 men (0.15%) in whom a missing vas was suspected but could not be confirmed, mostly due to the absence of a PVSA to confirm sterility or a history of prior surgery or scrotal anomaly that might account for the missing vas. The study of Miller and colleagues highlights three relevant aspects for practicing urologists that need to be discussed further. First, the importance of physical examination before the vasectomy and during fertility evaluation. Second, the role of post-vasectomy semen analyses, and lastly, the importance of surgical planning in difficult vasectomy cases. Palpation of the vas deferens is essential and should be included as part of the routine physical examination in all men seeking vasectomy or fertility (6). The finding of a missing vas should prompt urologists to order an abdominal ultrasound study to detect any renal anomalies (6). In healthy men seeking vasectomy, it might be argued that ultrasound is unnecessary as the finding of a single kidney is not clinically relevant. An objection is that although up to 80% of men with a congenital unilateral absence of vas deferens (CUAVD) have ipsilateral renal agenesis, the kidney may be present and other renal malformations such as ectopia, malrotation, fusion or polycystic disease may occur (7). Despite not warranting further intervention, informing the affected men that they have only one kidney or a renal anomaly is good medical practice as it may prompt such men to take a better life-style, thus preventing doi: 10.1590/S1677-5538.IBJU.2016.05.03

2 citations


Cites background from "2016 Laboratory guidelines for post..."

  • ...In recent guidelines issued conjointly by the British Andrology Society and the British Association of Urological Surgeons, assessment of one semen specimen preferably examined within 1 hour of the collection in a laboratory that uses proper methods- is enough to confirm sterility if no sperm are seen (14)....

    [...]


Journal ArticleDOI
TL;DR: The development (from an existing service) and subsequent United Kingdom Accreditation Service (UKAS) accreditation of andrology testing in a District General Hospital setting is described, describing key areas for development and utilising cytopathology and histopathology staff of various grades and thus providing one avenue of skill redeployment for those cy topathology staff who will no longer provide morphological screening expertise to the CSP.
Abstract: The change to HPV testing as the primary screening modality is under way or imminent in the Cervical Screening Programmes (CSP) of the UK nations. This will necessitate major structural changes in all cytopathology laboratories, both in those that continue to provide a service to the CSP and those that do not. This article describes the development (from an existing service) and subsequent United Kingdom Accreditation Service (UKAS) accreditation of andrology testing in a District General Hospital setting, describing key areas for development and utilising cytopathology and histopathology staff of various grades and thus providing one avenue of skill redeployment for those cytopathology staff who will no longer provide morphological screening expertise to the CSP. This article is protected by copyright. All rights reserved.

1 citations


Journal ArticleDOI
TL;DR: This study confirmed that the ligation and excision with fascial interposition vasectomy technique is associated with an unacceptable risk of failure and surgeons should use more effective occlusion techniques to reduce the failure risk to below 1% as recommended by the American Urology Association.
Abstract: Objective To evaluate the occlusive failure risk of ligation and excision with fascial interposition vasectomy technique. There are doubts about the effectiveness of this technique largely used in Asia and Latin America. Study design We conducted a prospective longitudinal observational descriptive study among men who underwent a vasectomy performed under local anesthesia in a clinic specializing in sexual and reproductive health services in Bogota, Colombia. Three urologists used the Percutaneous No-Scalpel Vasectomy technique to isolate the vas deferens. They then ligated the vas, excised a 1 cm segment between ligations, and ligated the fascia on the prostatic end to cover the testicular end. We requested all patients to submit a semen sample three months after the vasectomy. We defined probable and confirmed vasectomy failure as 1–4.9 million sperm/ml and 5 million sperm/ml or more or any number of motile sperm observed on the last semen sample available, respectively. Results Among 1149 participants, 581 (51%) had at least one post-vasectomy semen analysis. The overall failure risk was 5.2% (30/581; 95% confidence interval [CI] 3.6%–7.3%) with probable and confirmed failure risk of 1.9% (11/581; 95% CI 1.1%–3.4%) and 3.3% (19/581; 95% CI 2.1%–5.1%), respectively. Older men and one urologist had statistically significant higher risk of overall failure. Conclusion Our study confirmed that the ligation and excision with fascial interposition vasectomy technique is associated with an unacceptable risk of failure. Implications Surgeons who use the ligation and excision with fascial interposition vasectomy technique and countries with large vasectomy programs in Asia and Latin America that still recommend this technique should consider adopting alternatives to reduce the failure risk to below 1% as recommended by the American Urological Association.

1 citations


Journal ArticleDOI
TL;DR: Attempts to improve detection of occasional non-motile sperm are futile, cost more and fail to reduce risk of inappropriate clearance, with uncertainty surrounding the diagnosis, this study describes the analysis of 10 years of PVSA.
Abstract: The increasingly stringent laboratory-approach to diagnosing azoospermia for post-vasectomy semen analysis (PVSA) continues to be at odds with the simpler approach desired by clinicians. This study describes the analysis of 10 years of PVSA and discusses the outcome in relation to risk, cost and assesses whether more stringent procedures are required. PVSA was performed on 4788 patients initially using a 2-test strategy (16 and 20 weeks post-surgery), moving to 1 test during 2013-2014. Azoospermia was confirmed by the analysis of 10 µl of semen followed by 10 µl of centrifuged pellet. In total, there were 9260 tests with a median of 1.93 tests/patient and 18.7 weeks to clearance. Surgical failure occurred in 1.75%, falling to 1.1% between 2011 and 2016. There were no cases of unwanted pregnancy, recanalization or complaints although misdiagnosis was detected in 1 case as a result of failure to confirm patient identification. Azoospermia performed according to World Health Organization (WHO) guidelines is sufficiently robust to confirm success/failure of vasectomy. With uncertainty surrounding the diagnosis, efforts to improve detection of occasional non-motile sperm are futile, cost more and fail to reduce risk of inappropriate clearance. Misdiagnosis is more likely from patient identification error and mitigation may include reverting to the safety net of a 2-test strategy.

References
More filters


Journal ArticleDOI
TL;DR: This guideline was peer reviewed by 55 independent experts during the guideline development process and recommended that vasectomy be considered for permanent contraception much more frequently than is the current practice in the U.S. and many other nations.
Abstract: Purpose: The purpose of this guideline is to provide guidance to clinicians who offer vasectomy services.Materials and Methods: A systematic review of the literature using the search dates January 1949-August 2011 was conducted to identify peer-reviewed publications relevant to vasectomy. The search identified almost 2,000 titles and abstracts. Application of inclusion/exclusion criteria yielded an evidence base of 275 articles. Evidence-based practices for vasectomy were defined when evidence was available. When evidence was insufficient or absent, expert opinion-based practices were defined by Panel consensus. The Panel sought to define the minimum and necessary concepts for pre-vasectomy counseling; optimum methods for anesthesia, vas isolation, vas occlusion and post-vasectomy follow up; and rates of complications of vasectomy. This guideline was peer reviewed by 55 independent experts during the guideline development process.Results: Vas isolation should be performed using a minimally-invasive vasect...

123 citations


Journal ArticleDOI
TL;DR: These guidelines aim to provide information and recommendations for physicians who perform vasectomies and to promote the provision of adequate information to the patient before the operation to prevent unrealistic expectations and legal procedures.
Abstract: Context: The European Association of Urology presents its guidelines for vasectomy. Vasectomy is highly effective, but problems can arise that are related to insufficient preoperative patient information, the surgical procedure, and postoperative follow-up. Objective: These guidelines aim to provide information and recommendations for physicians who perform vasectomies and to promote the provision of adequate information to the patient before the operation to prevent unrealistic expectations and legal

112 citations


"2016 Laboratory guidelines for post..." refers background in this paper

  • ...It is always important for patients to be warned that a vasectomy may apparently fail at any time, though the actual chance of this is rare, at less than 1% if correctly performed [3-8], with some reports suggesting that temporary reappearance of sperm may occur a year after clear PVSA [9]....

    [...]


Journal ArticleDOI
TL;DR: Pharmacological stimulation of sperm motility may increase yields but, for in vitro fertilization (IVF), such spermatozoa must be used to inseminate oocytes as soon as possible after exposure to the stimulant, although after its removal.
Abstract: Because seminal plasma contains factors that inhibit the fertilizing ability of spermatozoa, it is essential that spermatozoa be separated from it quickly and efficiently. Although the success of a sperm preparation method is often assessed by the yield of motile spermatozoa, the choice of a method also depends on its technical complexity, the materials and apparatus required and time costs. Any exposure of spermatozoa during preparation to factors that may cause iatrogenic sperm dysfunction must obviously be avoided. Consequently, methods involving centrifugal washing prior to the selection of motile spermatozoa should be avoided. Direct swim-up from semen is the simplest way to obtain highly motile sperm populations and can be a very rapid procedure with normal semen samples. Two-layer discontinuous Percoll gradients give excellent yields when the lower layer contains 81% (v/v) Percoll. However, for severely asthenozoospermic cases the results can be disappointing and a Nycodenz gradient may be better, although the 'mini-Percoll' technique might be useful if special care is taken to protect the spermatozoa from damage induced by free radicals. In such cases the migration-sedimentation approach can also be successful. Abnormal samples, especially those with increased viscosity, may benefit from prior dilution with culture medium, or even chymotrypsin-induced liquefaction, before density gradient centrifugation. Finally, pharmacological stimulation of sperm motility may increase yields but, for in vitro fertilization (IVF), such spermatozoa must be used to inseminate oocytes as soon as possible after exposure to the stimulant, although after its removal.

108 citations


Journal ArticleDOI
01 Dec 1984-BJUI
TL;DR: There were six cases of late recanalisation in men previously thought sterile by two consecutive azoospermic analyses 4 months after vasectomy, not influenced by the operative technique used, but varied markedly between individual surgeons.
Abstract: Sixteen thousand, seven hundred and ninety-six men underwent vasectomy between 1970 and December 1983 and have been reviewed. Post-operative side effects were few and significant complications were reported in 0.9%. Failure to achieve sterility occurred in 72 men, 69 of whom have been analysed. The early recanalisation rate was 0.36%. This rate was not influenced by the operative technique used, but varied markedly between individual surgeons. Experience and care with technique should result in a failure rate of 0.2% or better. There were six cases of late recanalisation in men previously thought sterile by two consecutive azoospermic analyses 4 months after vasectomy.

102 citations