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The ‘Pleasure&Pregnancy’ web-based interactive educational programme versus expectant management in the treatment of unexplained subfertility: protocol for a randomised controlled trial

BMJ open, 2019-07, Vol.9 (7), p.e025845-e025845 [Peer Reviewed Journal]

Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ;2019 Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2019 ;ISSN: 2044-6055 ;EISSN: 2044-6055 ;DOI: 10.1136/bmjopen-2018-025845 ;PMID: 31289062

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  • Title:
    The ‘Pleasure&Pregnancy’ web-based interactive educational programme versus expectant management in the treatment of unexplained subfertility: protocol for a randomised controlled trial
  • Author: Dancet, Eline A F ; D’Hooghe, Thomas M ; Dreischor, Felicia ; van Wely, Madelon ; Laan, Ellen T M ; Lambalk, Cornelius B ; Repping, Sjoerd ; Custers, Inge M
  • Subjects: Acquired immune deficiency syndrome ; AIDS ; Consortia ; Counseling ; Couples ; Evidence-based medicine ; Family medical history ; Fertility ; Gynecology ; HIV ; Human immunodeficiency virus ; Infertility ; Obstetrics ; Pregnancy ; Prostate cancer ; Quality of life ; Quantitative psychology ; Questionnaires ; Reproductive Medicine ; Sperm
  • Is Part Of: BMJ open, 2019-07, Vol.9 (7), p.e025845-e025845
  • Description: IntroductionMany subfertile couples are diagnosed with (relatively) unexplained subfertility and a good prognosis. National professional guidelines (eg, the Netherlands and UK) advise ‘expectant management (EM)’ for 6–12 months, in which no interaction with healthcare staff is offered. Underpowered studies indicate that face-to-face sex-counselling increases the ongoing pregnancy rates of these couples. In patients with other conditions, web-based interactive educational programmes have the same effect on sexual functioning as face-to-face sex counselling. The ‘Pleasure&Pregnancy randomised controlled trial (RCT)’ will examine in couples with unexplained subfertility and a good prognosis whether a new web-based interactive educational programme results in a higher chance of naturally conceiving an ongoing pregnancy within 6 months as compared with EM.Methods and analysisA multicentre RCT with cost-effectiveness analysis will include heterosexual couples diagnosed with (relatively) unexplained subfertility and a good prognosis in Dutch and Belgian secondary or tertiary fertility clinics. Couples will be randomised between 6 months of EM and 6 months of the Pleasure&Pregnancy-programme. This new web-based interactive educational programme includes eight progressive modules of information (on the biology of conception and pleasurable sex) and sensate focus, couple communication and mindfulness exercises. Couples are offered interaction with their coaches via email and can take part in three moderated chat sessions with peers. The primary outcome of this RCT is the probability of naturally conceiving an ongoing pregnancy within 6 months after randomisation. Secondary outcomes include time-to-pregnancy, live birth rate, costs, sexual functioning and personal and relational well-being. Analysis will be according to intention to treat.Ethics and disseminationThis study has been approved by the Medical Ethical Committees of the Academic Medical Centre (the Netherlands) and the Leuven University Hospital (Belgium). The findings of this RCT will be disseminated through presentations at international scientific meetings and peer-reviewed publications.Trail registration numberNTR5709; Pre-results.
  • Publisher: England: BMJ Publishing Group LTD
  • Language: English
  • Identifier: ISSN: 2044-6055
    EISSN: 2044-6055
    DOI: 10.1136/bmjopen-2018-025845
    PMID: 31289062
  • Source: ProQuest One Psychology
    BMJ Open Access Journals
    Geneva Foundation Free Medical Journals at publisher websites
    PubMed Central
    Directory of Open Access Journals
    ROAD: Directory of Open Access Scholarly Resources
    ProQuest Central
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