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Guidance

The British Fertility Society members share a formidable amount of expertise. Our purpose is to ensure that we provide impartial expert guidance in complex areas of practice that is both evidence based and practical.

The Policy and Practice Committee welcomes suggestions of areas where such guidance would be valued and tapping into that expertise, commissions reviews and analyses often in collaboration with sister organisations in order to guide best practice. P&P documents are shared with members prior to peer review for publication and are widely cited resources.

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Guidance

A joint BFS and ARCS guideline

Abstract

This article reviews the evidence regarding the safety and efficacy of intra-cytoplasmic sperm injection (ICSI) in order to provide evidence-based clinical and laboratory guidelines and recommendations for use of ICSI within an assisted reproductive technology (ART) service. The guidelines will address the evidence for the use of ICSI rather than conventional IVF insemination; the use of ART techniques supplementary to ICSI; and risks associated with ICSI. This article is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment. Other plans of management may be appropriate, taking into account the needs and medical history of the patient, available resources, and institutional or clinical practice limitations. The Executive Committees of the British Fertility Society (BFS) and Association of Reproductive and Clinical Scientists (ARCS) have approved this report. It was reviewed by members of BFS and ARCS and their input was considered in the preparation of the final document. This article will not consider specific details concerning technical aspects of the ICSI procedure.

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Abstract

This article reviews the evidence regarding human oocyte cryopreservation by slow freezing and vitrification and provides evidence-based clinical and laboratory guidelines on the effectiveness and safety of these technologies. The guidelines address the stage of oocyte maturity; cryopreservation and thawing/warming using slow cooling or vitrification; techniques used for insemination of thawed/warmed oocytes; information and support counselling. These are an update of previous guidelines. The following outcome measures were examined: cryosurvival, fertilisation rate, cleavage rate, implantation and clinical pregnancy rate, miscarriage rate, live birth rate, psychosocial wellbeing, health of resulting children. This update does not include recommendations specific to fertility preservation for defined patient groups and specific ovarian stimulation regimens as they are covered in detail in recent guidance from the European Society of Human Reproduction and Embryology (ESHRE).

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Recurrent implantation failure (RIF) is defined as the absence of a positive pregnancy test after three consecutive transfers of good quality embryos. There remains significant variation in clinical practice in the management of RIF. This British Fertility Society (BFS) Policy and Practice guideline analyses the evidence for investigations and therapies that are employed in RIF and provides recommendations for clinical practice and for further research. Evidence for investigations of sperm and egg quality, uterine and adnexal factors, immunological factors and thrombophilia, endocrine conditions and genetic factors and for associated therapies have been evaluated. This guideline has been devised to assist reproductive medicine specialists and patients in making shared decisions concerning management of RIF. Finally, suggestions for research towards improving understanding and management of RIF have also been provided.

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Abstract

Varicoceles are reported to be present in a significant proportion of men presenting with subfertility and are more common amongst this group than in the general population. Opinion still remains divided amongst clinicians managing male factor infertility as to whether varicoceles alter the probability of spontaneous conception and/or pregnancy and live birth rates after fertility treatment. The debate as to whether varicoceles should be treated or not has intensified in recent years. This is due to the concerns regarding the impact of varicoceles on not only conventional semen parameters, but also the potential effects that they may have at the cellular level (an increase in circulating reactive oxygen species (ROS) resulting in sperm DNA fragmentation, even when conventional semen parameters are within the normal reference ranges). It has been suggested that treating the varicocele may result in improvements in the semen parameters, the fertilization and pregnancy rates for both spontaneous pregnancy as well as following in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment. ICSI can still be used for Assisted Reproduction Treatment (ART) in the presence of suboptimal semen parameters. However, it is an invasive and expensive technique with potential adverse effects on the offspring. As far as we are aware, there are no randomized controlled trials comparing the clinical/cost effectiveness of varicocele treatment versus the immediate use of ICSI on pregnancy rates. Previous modelling exercises are old and do not take into consideration current practices and trends such as rising female age and time to pregnancy. The conflicting advice that patients sometimes receive, challenges our commitment to evidence-based practice. The only way to resolve the controversy is to undertake an appropriately powered randomized trial, assessing clinical- and cost-effectiveness and the time to pregnancy following varicocele treatment and comparing this to a no treatment group.

 

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This article updates the 2008 UK guidelines for the medical and laboratory screening of sperm, egg and embryo donors. This was achieved by a working group composed of representatives from: the Association of Biomedical Andrologists, the Association of Clinical Embryologists, the British Andrology Society and the British Fertility Society, with subsequent review and commentary from their respective memberships. Information and guidance on core facts which should be made evident to all parties involved in donation are provided. Changes with regard to transmissible disease screening include: (i) extended guidance regarding history taking, risk factors and deferral periods; (ii) recommended quarantine period for donors screened by Nucleic Acid Testing (NAT) and serology is now 3 months; (iii) recommended quarantine period for donors screened by serology alone is legally required to be 6 months; (iv) if donor oocytes, or embryos created with donor oocytes, are cryopreserved then the quarantine period should be observed as best practice. We further recommend that consideration be given to HPV vaccination of women who outside of insemination may not be exposed to HPV. For heritable diseases, the discussion and assessment of genetic risk have been fundamentally reviewed in light of technological advances. After review of scientific evidence, it has also been deemed acceptable for men to donate sperm up to their 46th birthday.

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Conscious sedation is a commonly used approach to provide pain relief during transvaginal oocyte retrieval. It has been shown to be effective with high levels of acceptability and patient satisfaction. Fundamental Standards and Development Standards in safe sedation practice have been set out by the Royal College of Anaesthetists and they recommend that Royal Colleges, in association with the relevant sub-specialty organizations, should develop guidelines on sedation methods appropriate to clinical practice in their sphere of influence. This Policy and Practice paper outlines the human resources and equipment necessary to optimize patients’ safety for the administration of intravenous (I.V.) sedation in assisted conception units, based on the most current evidence and guidance available.

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Fertility preservation in the female poses several challenges due to the invasive nature of the techniques available to achieve it. The guideline aims to bring together the evidence available for the measures for fertility preservation and their outcome. The guideline addresses fertility preservation for medical reasons and includes both oncological and non-oncological causes. The techniques that the guideline considers are: (i) embryo and oocyte cryopreservation; (ii) ovarian tissue cryopreservation; (iii) GnRH agonist suppression and (iv) ovarian transposition. Although ovarian tissue cryopreservation is still considered experimental, the availability of this technique is gaining momentum as more live births from auto-transplanted tissue are reported. The guideline also highlights use of current treatment modalities for benign and malignant conditions that have a better fertility sparing profile. The guideline recommends a multidisciplinary approach in counselling women and girls about the risk to their fertility and available techniques. The role of psychological support in assisting women and girls with decision-making is highlighted. The guideline also highlights the risks associated with these techniques. Women need to be medically fit to undergo invasive procedures. Fertility preservation techniques are appropriate when treatment has curative intent. Fertility preservation is a subject of on-going research on outcomes of different techniques and at the time of publication, studies are still likely to emerge adding to the available literature.

 

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A significant number of multiple pregnancies and births worldwide continue to occur following treatment with Assisted Reproductive Technologies (ARTs). Whilst efforts have been made to increase the proportion of elective single embryo transfer (eSET) cycles, the multiple pregnancy rate or MPR remains at a level that most consider unacceptable given the associated clinical risks to mothers and babies, and the additional costs associated with neonatal care of premature and low birth weight babies. Northern Europe, Australia and Japan have continued to lead the way in the adoption of eSET. Randomised controlled trials or RCTs, meta-analyses and economic analyses support the implementation of an eSET policy, particularly in light of recent advances in ARTs. This paper provides a review of current evidence and an update to the eSET guidelines first published by Cutting et al. (2008) intended to assist ART clinics in the implementation of an effective eSET policy.

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Abstract

Embryo selection to improve pregnancy rates remains a significant challenge in IVF. Non-invasive and invasive methods of embryo selection include morphological assessment, metabolomics, time-lapse imaging and preimplantation genetic screening. To date, none has been shown conclusively to yield improved implantation and live birth rates. This review summarises current understanding of methods for embryo selection.

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Abstract

Optimisation of the environment favourable for satisfactory ovarian response to stimulation and successful embryo implantation remains at the core of assisted conception programmes. The evidence base for the routine use of different adjuvants, alone or in combination, for women undergoing their first in vitro fertilisation (IVF) treatment cycle and for those with poor prognosis is inadequate. The aim of this document is to update the last review of the available literature carried out by the British Fertility Society Policy and Practice Committee (BFS P&P) published in 2009 and to provide fertility professionals with evidence-based guidance and recommendations regarding the use of immunotherapy, vasodilators, uterine relaxants, aspirin, heparin, growth hormone, dehydroepiandrosterone, oestrogen and metformin as adjuvants in IVF. Unfortunately despite the lapse of 5 years since the last publication, there is still a lack of robust evidence for most of the adjuvants searched and large well-designed randomised controlled trials are still needed. One possible exception is metformin, which seems to have a positive effect in women with polycystic ovary syndrome undergoing IVF. Patients who are given other adjuvants on an empirical basis should always be informed of the lack of evidence and the potential side effects.

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The UK Department of Health’s consultation on the future of the Human Fertilisation and Embryology Authority (HFEA) presented an opportunity to review current practice in relation to donor conception (DC) and make recommendations for improving services to those seeking fertility treatment, to families with donor conceived children and those of donors, and to those seeking later information. The year 2023 marks the start of post-2005 donor conceived adults having statutory access to identifying information about their donor(s); some adults with pre-2005 donors will have access sooner if the donor(s) re-registers as ‘willing to be identified’. This paper examines current practice in UK licensed treatment centres in collecting and disseminating donor information and in supporting donors and prospective parents. Further, it considers current HFEA functions concerning DC including its responsibilities for the Register of Information and Donor Sibling Link and its approach to policy making, regulation and the release of information from these Registers to applicants. Proposals for how these functions could be carried out in the future are set out together with recommendations for national support and intermediary services. The key evidence available to support these recommendations is outlined.

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Abstract

Before planning an assisted conception treatment cycle, a thorough assessment of the woman’s hormone profile and ovarian reserve is essential to aid the decision on the appropriate protocol for controlled ovarian hyperstimulation (COH). There is insufficient evidence to recommend the use of one type of gonadotrophins over another. There is no benefit of luteinising hormone (LH) supplementation in cycles stimulated with follicle stimulating hormone alone in an unselected population. There is some evidence to suggest a potential benefit of LH supplementation in patients with a history of poor ovarian response to stimulation and in those older than 35 years. The long gonadotrophin releasing hormone (GnRH) agonist protocol is the most widely used and is the preferred protocol in the unselected population of women undergoing COH for in vitro fertilisation or intra-cytoplasmic sperm injection. The GnRH antagonist protocol is best used for known or suspected high responders, including women with PCOS, as it reduces the risk of OHSS. There is a lack of robust evidence to suggest that the GnRH agonist protocol is better than the GnRH antagonist protocol in poor responders. The prolonged GnRH agonist protocol is advantageous in women who are undergoing COH due to pelvic endometriosis. Oral contraceptive pill pre-treatment adversely affects the IVF outcome in GnRH antagonist cycles, but not in GnRH agonist cycles.

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Abstract

Reports on the influence of semen parameters on natural or assisted pregnancy are contradictory, suggesting that the many confounding variables which contribute to outcome have not been taken into account. However, it is possible to derive some consensus for both natural and assisted conception by focussing on studies which use WHO-recommended semen analysis on relatively large populations, applying appropriate statistics and accounting for ‘female factors’. The concentration of progressively motile sperm has consistently been shown to be the most predictive factor with regard to outcome. Around 64% of studies suggest that a reasonable chance of success with artificial insemination requires at least 5 × 10⁶ motile sperm and this is supported by the WHO’s revised reference range for natural conception. Sperm morphology remains controversial, with a lack of standardisation across centres, the adoption of ever-stricter scoring criteria and changing reference values. Antisperm antibodies do not appear to influence outcome independently of sperm motility and agglutination. Sperm DNA damage appears to be related to sperm quality, embryo development and pregnancy loss, yet there remains no consensus on the best testing procedures, clinical reference values and how patients with an adverse result should be managed. In conclusion, laboratories should continue to focus on reducing the uncertainty and improving the quality of their basic semen analysis.

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Abstract

Preimplantation genetic screening (PGS) has been proposed as a method to improve the success rates of assisted conception in certain indications. Most commonly the technique involves analysing part of the karyotype of one or two biopsied blastomeres by fluorescence in situ hybridisation and thus detecting aneuploid embryos which are then not transferred into the uterus. Proposed indications include advanced maternal age, repeated IVF failure and recurrent miscarriage. While there are a considerable number of reports of the use of this technique, there are only two randomised controlled trials reported at present, both for the indication of advanced maternal age. Neither show an increase in live birth rate, and indeed the more recent (using a relatively low age cut-off of 35 years) suggests that live birth rate is reduced by the use of PGS. Methodological aspects of both studies are discussed. It remains possible that PGS may be of benefit under certain circumstances. However at present patients should be informed that there is no robust evidence that PGS for advanced maternal age improves live birth rate per cycle started, and PGS should preferably be offered within the context of robustly designed randomised trials performed in suitably experienced centres.

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Abstract

The aim of this article is to review the evidence regarding human embryo cryopreservation and to provide evidence-based clinical and laboratory guidelines. In addition, the article highlights topics suitable for research and audit.

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Abstract

Obesity has a significant adverse impact on reproductive outcome. It influences not only the chance of conception but also the response to fertility treatment, and increases the risk of miscarriage, congenital anomalies and pregnancy complications in addition to potential adverse effects on long term health of both mother and infant. Women should aim for a normal BMI before starting any form of fertility treatment. Treatment should be deferred until the BMI is less than 35 kg/m2, although in those with more time (e.g., less than 37 years; normal serum FSH concentration) a weight reduction to a BMI of less than 30 kg/m2 is preferable. Clinicians should consider deferring treatment to women outside these guidelines. Women should be provided with assistance to lose weight, including psychological support, dietary advice, exercise classes and where appropriate, weight reducing agents or bariatric surgery. Even a moderate weight loss of 5-10% of body weight can be sufficient to restore fertility and improve metabolic markers.

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Abstract

Sperm and embryo cryopreservation practice in licensed clinics in the UK endorsed by The British Fertility Society.

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Policy & Practice
Harish Bhandari
Chair of Policy and Practice
Deputy Chairs: Mariano Mascarenhas and Rina Agrawal
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