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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

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Reproductive medicine
Protocol
The ‘Pleasure&Pregnancy’ web-based interactive educational programme versus expectant management in the treatment of unexplained subfertility: protocol for a randomised controlled trial
  1. Eline A F Dancet1,2,3,
  2. Thomas M D’Hooghe1,
  3. Felicia Dreischor3,
  4. Madelon van Wely3,
  5. Ellen T M Laan4,
  6. Cornelius B Lambalk5,
  7. Sjoerd Repping3,
  8. Inge M Custers3
  1. 1 Department of Development and Regeneration, KU Leuven - University of Leuven, Leuven, Belgium
  2. 2 Postdoctoral fellow, Research Foundation - Flanders, Belgium
  3. 3 Department of Obstetrics and Gynecology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, The Netherlands
  4. 4 Department of Sexology and Psychosomatic Obstetrics/Gynecology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, The Netherlands
  5. 5 Department of Obstetrics and Gynaecology, Reproduction and Development, Amsterdam University Medical Centre, Free University of Amsterdam, Amsterdam, The Netherlands
  1. Correspondence to Dr Eline A F Dancet; eline.dancet{at}kuleuven.be

Abstract

Introduction Many 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 analysis A 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 dissemination This 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 number NTR5709; Pre-results.

  • subfertility
  • randomized controlled trial
  • sexuality
  • patient education

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/.

https://doi.org/10.1136/bmjopen-2018-025845

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    Footnotes

    • Contributors EAFD, IMC, TMD, CBL, ETML, SR and MvW designed the trial, developed the protocol and applied for funding. EAFD, IMC and FD applied for ethical approval and implemented the logistics of the trial. All authors read, revised and approved the final manuscript.

    • Funding This work was supported by the Netherlands Organization for Health Research and Development (ZonMW; reference: 843001605). EAFD is holder of a postdoctoral fellowship of the Research foundation Flanders (Belgium).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.