Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jul 9;9(7):e025845.
doi: 10.1136/bmjopen-2018-025845.

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

Eline A F Dancet  1   2   3 , Thomas M D'Hooghe  1 , Felicia Dreischor  3 , Madelon van Wely  3 , Ellen T M Laan  4 , Cornelius B Lambalk  5 , Sjoerd Repping  3 , Inge M Custers  3
Affiliations

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

Eline A F Dancet et al. BMJ Open. .

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.

Keywords: patient education; randomized controlled trial; sexuality; subfertility.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow-chart of the Pleasure&Pregnancy-RCT. (PROMs, patient reported outcome measures; RCT, randomised controlled trial).
See this image and copyright information in PMC

References

    1. Boivin J, Bunting L, Collins JA, et al. International estimates of infertility prevalence and treatment-seeking: potential need and demand for infertility medical care. Hum Reprod 2007;22:1506–12. 10.1093/humrep/dem046 - DOI - PubMed
    1. van der Steeg JW, Steures P, Eijkemans MJ, et al. CECERM study group (Collaborative Effort for Clinical Evaluation in Reproductive Medicine). Pregnancy is predictable: a large-scale prospective external validation of the prediction of spontaneous pregnancy in subfertile couples. Hum Reprod 2007;22:536–42. - PubMed
    1. NVOG Richtlijn: Onverklaarde subfertiliteit: 2010-09-15, Versie: 1.0. https://www.nvog.nl/wp-content/uploads/2017/12/Onverklaarde-subfertilite... (Accessed 23 Oct 2018).
    1. Steures P, van der Steeg JW, Hompes PG, et al. Collaborative Effort on the Clinical Evaluation in Reproductive Medicine. Intrauterine insemination with controlled ovarian hyperstimulation versus expectant management for couples with unexplained subfertility and an intermediate prognosis: a randomised clinical trial. Lancet 2006;368:216–21. - PubMed
    1. van Asselt K, Hinloopen RJ, Silvius AM, et al. Preconceptiezorg, wiens zorg eigenlijk? Huisarts Wet 2010;53:2–14. 10.1007/s12445-010-0002-y - DOI

Publication types

Associated data