Building an evidence base for IVF ‘add-ons’

Macklon, N.S; Ahuja, KK; Fauser, Bcjm

doi:10.1016/j.rbmo.2019.04.005

Cited by 55 publications

(55 citation statements)

References 17 publications

(18 reference statements)

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“…Clinicians tend to grasp any new idea that can potentially improve results ( Ben Rafael, 2020a ), also to demonstrate that they are competitive and updated, but unfortunately even after many years of practice, most add-ons have been deemed not proven ( Macklon et al , 2019 ). New tests, like the ERA, until shaped and proven, should be offered only under research protocols that separate compounding factors, considering all the above reservations, and keeping in mind that freezing embryos is not risk free.…”

Section: Summary and Discussionmentioning

confidence: 99%

Endometrial Receptivity Analysis (ERA) test: an unproven technology

Ben‐Rafael

2021

Human Reproduction Open

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This article addresses the limitations of the endometrial receptivity array (ERA) methodology to increase implantation. Such limitations vary from the assumed inconsistency of the endometrial biopsy, the variable number of genes found to be dysregulated in endometrium samples without the embryonal-induced effect, the failure to account for the simultaneous serum progesterone level, and the expected low percentage of patients who may need this add-on procedure, to the difficulties in synchronising the endometrium with hormone replacements in successive cycles and the inherent perinatal risks associated with routine cryopreservation of embryos. Without a gold standard to compare, the claim that the window of implantation (WOI) might be off by ±12 h only requires a good argument for the advantage it provides to human procreation, knowing that embryos can linger for days before actual embedding starts and that the window is actually a few days. The intra-patient variations in the test need to be addressed. In summary, like all other add-ons, it is doubtful whether the ERA test use can significantly enhance implantation success rates.

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Section: Summary and Discussionmentioning

confidence: 99%

Endometrial Receptivity Analysis (ERA) test: an unproven technology

Ben‐Rafael

2021

Human Reproduction Open

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“…As a response, the HFEA started an independent assessment and in 2017 launched a webpage ( HFEA, 2019b ) where patients could find efficiency and safety information on the 9 most widely-used add-ons. This initiative aimed to improve informed choice ‘without completely denying patient-access to potentially beneficial innovations’ ( Macklon et al, 2019 ). However, the HFEA also adopted a conventional EBM perspective on evidence, which is summarised in a traffic light system: green light, for treatments with more than one quality RCT; amber light, for treatments with a small or conflicting body of evidence and further research required; red light, where no evidence of safety or effectiveness exists.…”

Section: The Discourse Of Evidence In Ivfmentioning

confidence: 99%

“…Repeated pleas to conduct more quality RCTs before routinely offering treatments to patients proliferated in the professional community ( Repping, 2019 ; Wilkinson et al, 2017 ). However, as some experts noted ( Macklon et al, 2019 ), the pursuit of the gold standard has, so far, left professionals in a difficult position: lacking robust evidence to make clinical decisions, while being condemned for using unproven treatments.…”

Section: The Discourse Of Evidence In Ivfmentioning

confidence: 99%

“…A second problem is the number of participants required to demonstrate a clinically- and statistically-significant impact on LBRs ( Stocking et al, 2019 ), where proving a 5% increase requires over 2500 patients ( Wilkinson et al, 2019 ). In a few successful cases, when good quality RCTs were finally published, the treatments assessed were already obsolete ( Macklon et al, 2019 ). Clinicians have attempted to circumvent the problem by using routinely collected data and large electronic databases.…”

Section: The Discourse Of Evidence In Ivfmentioning

confidence: 99%

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The trouble with IVF and randomised control trials: Professional legitimation narratives on time-lapse imaging and evidence-informed care

Perrotta

Geampana

2020

Social Science & Medicine

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Focusing on the case of time-lapse imaging (TLI), this paper analyses how medical professionals negotiate the use of new ‘add-on’ fertility treatments in light of the limited evidence available. The data produced by TLI technologies is meant to help professionals identify the best embryo to be implanted. Embryo selection is essential in IVF practice for increasing pregnancy rates and reducing the negative effects of repeated failures. More than 5 years after the introduction of TLI in IVF labs, however, there has been no conclusive randomised control trial (RCT) evidence to show that the tools do indeed have a significant impact on pregnancy rates. Nonetheless, many public clinics in the UK have adopted such technologies. Consequently, our research asks: How is the use of TLI tools legitimised by professionals, in light of contradictory evidence? Focusing on 25 semi-structured staff interviews, we argue that professionals use several strategies to legitimise the use of TLI in the clinic without, however, challenging the tenets of evidence-based medicine (EBM) and the value it places on RCTs. Rather, professionals emphasise various advantages that TLI offers, including its use as a lab tool, its potential for knowledge production in embryology, and the role it plays in the management of patient expectations and course of treatment. This paper contributes to debates on the role of EBM in modern medicine and fertility care specifically – an area where this inter-relationship has been underexplored. We conclude by suggesting avenues towards a more nuanced understanding of EBM as it relates to IVF treatment and a rapidly changing biotechnology context.

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“…This current clinical story has been fully covered in a specific article from our group in this e-book (Yovich et al, under review) which traces the evolution of the “poor-prognosis” concept and indicates that the observational and retrospective studies for GH are strongly supportive of this adjuvant over others which have been reported. Given the recent recognition of the limitations of RCT application in the area of adjuvants or “add-ons” (1), we believe our data reports on GH may be the best achievable currently.…”

Section: Introductionmentioning

confidence: 98%

The Concept of Growth Hormone Deficiency Affecting Clinical Prognosis in IVF

et al. 2019

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The current understanding of human growth hormone (hGH; here GH) action is that the molecule is a 191-amino acid, single-chain polypeptide that is synthesized, stored and secreted by the somatotroph cells within the lateral wings of the anterior pituitary gland. It can be classified as a protein (comprising more than 50 amino acids) but true proteins have tertiary and quaternary chains creating a more complex structure, hence GH is usually classified as a polypeptide. GH is normally secreted at night during sleep and promotes skeletal, visceral and general body growth through the action of somatomedins or IGFs, notably IGF-1. In some tissues, GH action is directed via specific receptors GHRs; these are most abundant in liver, adipose and muscle tissues but have also been shown in granulosa cells, testicular tissues and on the oocyte, as well as in glandular cells of the luteal phase endometrium and decidua; such findings being recent and minimally researched to now. Following engagement with its receptor, the transduction process activates multiple signaling proteins. These all lead to extensive metabolic and mitogenic (growth promoting) responses. Clinically, GH is known to have an important role in pubertal development and is a key hormone for the vigor associated with adolescence and early adult life stages but has a faded presence and role for later adulthood, beyond age 30 years, and is minimally detected in advanced age, beyond 40 years. In association with the rapidly increasing trend for delaying reproduction beyond age 35 years, GH is being widely researched now as a potential adjuvant for infertility treatment in this group who, studies consistently show, have a poorer prognosis than younger females when relying on autologous oocytes. The idea that the age-related reduction in fertility prognosis is a feature of growth hormone deficiency is supported by our studies showing an elevated binding protein IGFBP-3/IGF-1 ratio and this can be reduced to a normal range (matching younger, good prognosis women) by the administration of GH as an adjuvant.

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Building an evidence base for IVF ‘add-ons’

Cited by 55 publications

References 17 publications

Endometrial Receptivity Analysis (ERA) test: an unproven technology

Endometrial Receptivity Analysis (ERA) test: an unproven technology

The trouble with IVF and randomised control trials: Professional legitimation narratives on time-lapse imaging and evidence-informed care

The Concept of Growth Hormone Deficiency Affecting Clinical Prognosis in IVF

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