scholarly journals Experiences of trial participants and site staff of participating in and running a large randomised trial within fertility (the endometrial scratch trial): a qualitative interview study

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e051698
Author(s):  
Robin Chatters ◽  
David White ◽  
Clare Pye ◽  
Ana Petrovic ◽  
Anya Sizer ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
In Vitro Fertilisation ◽  
Amount Of Information ◽  
Qualitative Interview Study ◽  
Site Staff ◽  
Endometrial Scratch ◽  
Randomised Controlled ◽  
Trial Participants

ObjectivesTo explore the experiences of endometrial scratch (ES) trial participants and site staff of trial recruitment and participation, in order to improve the experience of participants in future trials.DesignQualitative study of a subset of participants in the ES randomised controlled trial and a subset of trial site staff.SettingA purposeful sample of 9 of the 16 UK Fertility Units that participated in the trial.ParticipantsA purposeful sample of 27 trial participants and 7 site staff.ResultsParticipants were largely happy with the recruitment practices, however, some were overwhelmed with the amount of information received. Interviewees had positive preconceptions regarding the possible effect of the ES on the outcome of their in vitro fertilisation (IVF) cycle, which often originated from their own internet research and seemed to be exacerbated by how site staff described the intervention. Some participants appeared to not understand that receiving the ES could potentially reduce their chances of a successful IVF outcome. Those randomised to the control arm discussed feeling discontent; site staff developed mechanisms of dealing with this.ConclusionsA lack of equipoise in both study participants and the recruiting site staff led to trial participants having positive preconceptions of the potential impact of the ES on their upcoming IVF cycle. Trial participants may not have understood the potential harms of participating in a randomised trial. The trial information sheet did not clearly state this; further research should assess how such information should be presented to potential participants, to proportionately present the level of risk, but to not unduly discourage participation. The amount of information fertility patients require about a research study should also be investigated, in order to avoid participants feeling overwhelmed by the amount of information they receive prior to starting IVF.Trial registration numberISRCTN23800982.

scholarly journals In vitro fertilisation (IVF) versus intracytoplasmic sperm injection (ICSI) in patients without severe male factor infertility: study protocol for the randomised, controlled, multicentre trial INVICSI

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e051058
Author(s):  
Sine Berntsen ◽  
Bugge Nøhr ◽  
Marie Louise Grøndahl ◽  
Morten Rønn Petersen ◽  
Lars Franch Andersen ◽  
...  
Keyword(s):  
Live Birth ◽  
Intracytoplasmic Sperm Injection ◽  
Controlled Trial ◽  
Male Partner ◽  
In Vitro Fertilisation ◽  
Male Factor Infertility ◽  
Male Factor ◽  
Fertilisation Rate ◽  
Randomised Controlled

IntroductionOver the last decades, the use of intracytoplasmic sperm injection (ICSI) has increased, even among patients without male factor infertility. The increase has happened even though there is no evidence to support that ICSI results in higher live birth rates compared with conventional in vitro fertilisation (IVF) in cases with nonmale factor infertility. The lack of robust evidence on an advantage of using ICSI over conventional IVF in these patients is problematic since ICSI is more invasive, complex and requires additional resources, time and effort. Therefore, the primary objective of the IVF versus ICSI (INVICSI) study is to determine whether ICSI is superior to standard IVF in patients without severe male factor infertility. The primary outcome measure is first live birth from fresh and frozen-thawed transfers after one stimulated cycle. Secondary outcomes include fertilisation rate, ongoing pregnancy rate, birth weight and congenital anomalies.Methods and analysisThis is a two-armed, multicentre, randomised, controlled trial. In total, 824 couples/women with infertility without severe male factor will be recruited and allocated randomly into two groups (IVF or ICSI) in a 1:1 ratio. Participants will be randomised in variable block sizes and stratified by trial site and age. The main inclusion criteria are (1) no prior IVF/ICSI treatment, (2) male partner sperm with an expected count of minimum 2 million progressive motile spermatozoa following density gradient purification on the day of oocyte pick up and (3) age of the woman between 18 and 42 years.Ethics and disseminationThe study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committee of the Capital Region of Denmark. Study findings will be presented, irrespectively of results at international conferences and submitted for publication in peer-reviewed journals.Trial registration numberNCT04128904. Pre-results.

scholarly journals The effect of a multifaceted empowerment strategy on decision making about the number of embryos transferred in in vitro fertilisation: randomised controlled trial

BMJ ◽  
2010 ◽  
Vol 341 (sep30 2) ◽  
pp. c2501-c2501 ◽  
Author(s):  
A. van Peperstraten ◽  
W. Nelen ◽  
R. Grol ◽  
G. Zielhuis ◽  
E. Adang ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
In Vitro Fertilisation ◽  
Randomised Controlled

scholarly journals Experiences of patients and physiotherapists with blended internet-based vestibular rehabilitation: a qualitative interview study

BJGP Open ◽  
2020 ◽  
Vol 4 (5) ◽  
pp. bjgpopen20X101092
Author(s):  
Vincent A van Vugt ◽  
Anja JThCM de Kruif ◽  
Johannes C van der Wouden ◽  
Henriëtte E van der Horst ◽  
Otto R Maarsingh
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Qualitative Interview ◽  
Vestibular Rehabilitation ◽  
Interview Study ◽  
Structured Interviews ◽  
Qualitative Interview Study ◽  
Vestibular Symptoms ◽  
Randomised Controlled

BackgroundInternet-based vestibular rehabilitation (VR) with physiotherapy support, known as blended VR, was effective in reducing vestibular symptoms in a recent randomised controlled trial. Blended VR is a complex intervention comprised of physiotherapeutic visits, the vertigo training website, and VR exercises. Because of these interacting components, it is important to understand how blended VR works, for whom it works best, and how it should ideally be delivered.AimTo investigate the experiences of both patients and physiotherapists with blended internet-based VR.Design & settingA qualitative interview study was performed with patients who received blended internet-based VR with physiotherapy support, and physiotherapists who provided this support.MethodSemi-structured interviews were conducted with 14 patients and eight physiotherapists after the 6-month follow-up of the randomised trial. All interviews were audio-recorded, transcribed, and thematically analysed.ResultsAccording to both patients and physiotherapists, the physiotherapist visits were useful in providing personal attention, helping patients safely execute exercises, and improving patients’ adherence to therapy. Some patients said they did not need physiotherapist support and, according to physiotherapists, both the necessity and the optimal way to deliver guidance differed greatly between patients. The Vertigo Training website and exercises provided patients with a sense of control over their symptoms. Patients reported that the VR exercises were easy to perform and most patients continued to use them long after the trial ended.ConclusionIn blended VR, physiotherapeutic visits appear to offer benefits above the vertigo training website and VR exercises alone. Physiotherapy support may best be used when individually tailored.

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