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VU Research Portal Tailored Expectant Management in Reproductive Medicine van den Boogaard, N.M. 2013 document version Publisher's PDF, also known as Version of record Link to publication in VU Research Portal citation for published version (APA) van den Boogaard, N. M. (2013). Tailored Expectant Management in Reproductive Medicine. General rights Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights. • Users may download and print one copy of any publication from the public portal for the purpose of private study or research. • You may not further distribute the material or use it for any profit-making activity or commercial gain • You may freely distribute the URL identifying the publication in the public portal ? Take down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. E-mail address: [email protected] Download date: 26. Sep. 2021 Tailored Expectant Management in Reproductive Medicine Noortje Moniek van den Boogaard Tailored Expectant Management in Reproductive Medicine Thesis, VU Medical Centre, Amsterdam This thesis was prepared at: - Division of Reproductive Medicine, Department of Obstetrics and Gynaecology, VU Medical Center, Amsterdam, The Netherlands - Centre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands - Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, The Netherlands The printing of this thesis was supported by: Stichting Gynaecologische Endocrinologie en Kunstmatige Voortplanting, Stichting Weten- schappelijk Onderzoek Gynaecologie VUmc, ABBOTT B.V., Ferring B.V., Goodlife Fertility and Merck Sharp & Dohme B.V. Cover design: Proefschriftmaken.nl || Uitgeverij BOXPress Printed & Lay Out by: Proefschriftmaken.nl || Uitgeverij BOXPress Published by: Uitgeverij BOXPress, ‘s-Hertogenbosch ISBN 978-90-8891-680-9 © 2013 Noortje Moniek van den Boogaard, Amsterdam, The Netherlands. VRIJE UNIVERSITEIT Tailored Expectant Management in Reproductive Medicine ACADEMISCH PROEFSCHRIFT ter verkrijging van de graad Doctor aan de Vrije Universiteit Amsterdam, op gezag van de rector magnificus prof.dr. F.A. van der Duyn Schouten, in het openbaar te verdedigen ten overstaan van de promotiecommissie van de Faculteit der Geneeskunde op donderdag 5 september 2013 om 13.45 uur in de aula van de universiteit, De Boelelaan 1105 door Noortje Moniek van den Boogaard geboren te Eindhoven promotoren: prof.dr. F. van der Veen prof.dr. B.W.J. Mol copromotoren: dr. P.G.A. Hompes dr. W.L.D.M. Nelen The art of medicine consists in amusing the patient while nature cures the disease. Voltaire. Aan mijn ouders 5 CONTENTS Chapter 1: Introduction and outline of this thesis 9 PART I Implementation of tailored expectant management 21 Chapter 2: Tailored expectant management: risk factors for non-adherence 23 Human Reproduction, Vol.26, pp. 1784–1789, 2011 Chapter 3: Patients’ and professionals’ barriers and facilitators of tailored expectant management in subfertile couples with a good prognosis of a natural conception 37 Human Reproduction, Vol.26, pp. 2122–2128, 2011 Chapter 4: Tailored expectant management: a nation wide survey to quantify patients’ and professionals’ barriers and facilitators 57 Human Reproduction, Vol. 27, pp. 1050-7, 2012 Chapter 5: Improving the implementation of tailored expectant management in subfertile couples; a cluster randomised trial 77 Implementation Science, Vol. 53, pp. 53-64, 2013 PART II Applicability of prognosis of natural conception 93 Chapter 6: Accessing fertility treatment in New Zealand: a comparison of the clinical priority access criteria with a prediction model for couples with unexplained subfertility 95 Human Reproduction, Vol.26, pp. 3037–3044, 2011 Chapter 7: The prognostic profile of subfertile couples and treatment outcome after expectant management, intrauterine insemination and in vitro fertilisation: a study protocol for the meta-analysis of individual patient data. 115 BJOG, Vol 119, pp. 953-7, 2012, 2012 6 Chapter 8: Prognostic profiles and the effectiveness of assisted conception: secondary analyses of individual patient data. 135 Human Reproduction Update, accepted for publication Chapter 9: General Discussion 163 Chapter 10: Summary in English and Dutch 179 List of Publications 191 Dankwoord 195 About the Author 201 7 8 CHAPTER 1 Introduction and outline of this thesis 9 Chapter 1 INTRODUCTION Subfertility is defined as a failure to conceive after at least one year of regular unprotected intercourse (Zegers-Hochschild et al. 2009). It affects approximately 10% of couples in their reproductive lives (Boivin et al. 2007; Gnoth et al. 2003). The incidence of subfertility is increasing in the developed world mainly due to postponement of maternity. After a basic fertility work up about 25% of couples is diagnosed with unexplained subfertility, 30% with a mild male factor, 5% with a severe male factor, 20% with an ovulation disorder and in 20% of the couples other diagnoses as tubal factor, cervical subfertility, endometriosis and sexual disorders are made (Brandes et al. 2010; Collins and Van 2004). In couples with unexplained or mild male subfertility the first step in the treatment cascade is often intra uterine insemination (IUI) with or without ovarian stimulation (OS). If 6-9 cycles of IUI with ovarian stimulation do not lead to a live birth (Custers et al. 2008), the second step in the treatment cascade for these couples is often In vitro fertilisation (IVF) (ESHRE 2008; NVOG: national guideline subfertility 2011). Intra Uterine Insemination The rationale for performing IUI is that motile spermatozoa are concentrated in a small volume and inseminated directly into the uterine cavity close to the released oocyte, bypassing the cervix. The aim of ovarian stimulation is to increase the number of oocytes available for fertilisation and to optimise timing of insemination. The first scientifically described homologous insemination dates from 1799, where the author describes how a man with severe hypospadias collected his semen in a syringe and introduced it into the vagina of his wife. The insemination was successful (Hogerzeil 1997). The first publication of a randomised clinical trial on intra uterine insemination in couples with poor semen quality was in 1984 (Kerin et al. 1984). This 3-armed trial compared IUI on the day of the luteinising hormone surge with intercourse in which timing was based on either the luteinising hormone surge or on the basal body temperature. After 39 inseminations, 8 women conceived. Intra uterine insemination was more successful than LH-timed intercourse (0/38; p<0.05) and natural intercourse timed by the basal temperature curves (1/34; p = 0.022). Since this first randomised controlled trial (RCT) on IUI, the number of IUI treatments with and without ovarian stimulation has increased rapidly. However, no national or international registrations are available concerning the exact number of treatments and pregnancy rates. One retrospective study estimated that 28,500 IUI cycles were performed in the Netherlands in 2003 with an ongoing pregnancy rate of 7% per cycle and with a multiple pregnancy rate of 9% (Steures et al. 2007c). The first Cochrane review was published in 2000 on IUI with or without ovarian stimulation (OS) for couples with male subfertility included 3,662 completed cycles and concluded that 10 IUI offers couples with male subfertility benefit over timed intercourse (TI), both in natural cycles (combined odds ratio with 95% confidence intervals: 2.4, 1.5 - 3.8) and in cycles with OS (combined odds ratio with 95% confidence intervals: 2.1, 1.3 - 3.5). Intrauterine insemination in cycles with OS improved the probability of conception compared with IUI in natural cycles but significance was not reached (Odds Ratio (OR) with 95% confidence intervals (CI): 1.7, 0.98 - 3.2). So, the authors concluded that intra-uterine insemination offered couples with male subfertility benefit over timed intercourse, both in natural cycles and in cycles with COH. In case of a severe semen defect (with more than 1 million motile sperm after semen preparation) IUI in natural cycles should be the treatment of first choice, but the value of COS needed to be further investigated in RCTs. (Cohlen et al. 2000). The most recent update of this Cochrane review on IUI for male subfertility was performed in 2007. For the comparison IUI versus timed intercourse both in natural cycles no evidence of difference between the probabilities of pregnancy rates per woman after IUI was found (OR 5.3, 95% CI 0.42 to 67). No statistically significant difference between pregnancy rates per couple for IUI with OS versus IUI could be found (OR 1.4, 95% CI 0.92 to 2.3). For the comparison of IUI versus TI both in stimulated cycles there was also no evidence of a statistically significant difference in pregnancy rates per couple either (OR 1.6, 95% CI 0.83 to 3.3). There were insufficient data available for adverse outcomes such as OHSS, multiple pregnancy, miscarriage rate and ectopic pregnancy to perform a statistical analysis. They concluded that there was insufficient evidence of effectiveness to recommend or advice against IUI with or without OS above TI, or vice versa. The authors thus recommended that large, high quality randomised controlled trials, comparing IUI with or without OS with pregnancy rate per couple as the main outcome of interest needed to be performed before firm conclusions can be drawn (Bensdorp et al. 2007). A recent update of a Cochrane review on IUI for couples with unexplained subfertility was published this year. One trial compared IUI in a natural cycle with expectant management and showed no evidence of increased live births (334 women: OR 1.6, 95% CI: 0.92 to 2.8).

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