1. IVF or IUI as first-line treatment in unexplained subfertility: the conundrum of treatment selection markers
- Author
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M. J. Pelinck, J. W. M. Maas, M.J.C. Eijkemans, Parvin Tajik, M. van Wely, Denise A. M. Perquin, G.J.E. Oosterhuis, Mohammad Hadi Zafarmand, Sjoerd Repping, Patrick M.M. Bossuyt, Judith Gianotten, M. D. A. Lambers, R. van Golde, F. van der Veen, Els Slappendel, A.J. Bensdorp, Ben W.J. Mol, R. I. Tjon-Kon-Fat, Other departments, Pathology, APH - Methodology, APH - Personalized Medicine, Amsterdam Reproduction & Development (AR&D), APH - Global Health, Other Research, Amsterdam Cardiovascular Sciences, Public and occupational health, Obstetrics and Gynaecology, Epidemiology and Data Science, Center for Reproductive Medicine, APH - Quality of Care, APH - Aging & Later Life, ACS - Atherosclerosis & ischemic syndromes, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), RS: GROW - R4 - Reproductive and Perinatal Medicine, Promovendi PHPC, Psychiatrie en Neuropsychologie, and Plastic, Reconstructive and Hand Surgery
- Subjects
Adult ,Male ,medicine.medical_specialty ,treatment selection markers ,marker-treatment interaction ,Pregnancy Rate ,medicine.medical_treatment ,Ethnic group ,Fertilization in Vitro ,Controlled ovarian hyperstimulation ,01 natural sciences ,IUI ,010104 statistics & probability ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Health care ,Journal Article ,unexplained subfertility ,Humans ,Medicine ,Comparative Study ,0101 mathematics ,Birth Rate ,Infertility, Male ,Insemination, Artificial ,COUPLES ,030219 obstetrics & reproductive medicine ,In vitro fertilisation ,business.industry ,Obstetrics ,Patient Selection ,Rehabilitation ,INTRAUTERINE INSEMINATION ,Obstetrics and Gynecology ,Prognosis ,medicine.disease ,Clinical trial ,Reproductive Medicine ,CONTROLLED OVARIAN HYPERSTIMULATION ,Sample size determination ,IVF ,Fertilization ,Female ,Live birth ,business ,IN-VITRO FERTILIZATION ,CLINICAL-TRIALS - Abstract
Study question Are there treatment selection markers that could aid in identifying couples, with unexplained or mild male subfertility, who would have better chances of a healthy child with IVF with single embryo transfer (IVF-SET) than with IUI with ovarian stimulation (IUI-OS)? Summary answer We did not find any treatment selection markers that were associated with better chances of a healthy child with IVF-SET instead of IUI-OS in couples with unexplained or mild male subfertility. What is known already A recent trial, comparing IVF-SET to IUI-OS, found no evidence of a difference between live birth rates and multiple pregnancy rates. It was suggested that IUI-OS should remain the first-line treatment instead of IVF-SET in couples with unexplained or mild male subfertility and female age between 18 and 38 years. The question remains whether there are some couples that may have higher pregnancy chances if treated with IVF-SET instead of IUI. Study design, size, duration We performed our analyses on data from the INeS trial, where couples with unexplained or mild male subfertility and an unfavourable prognosis for natural conception were randomly allocated to IVF-SET, IVF in a modified natural cycle or IUI-OS. In view of the aim of this study, we only used data of the comparison between IVF-SET (201 couples) and IUI-OS (207 couples). Participants/materials, setting, methods We pre-defined the following baseline characteristics as potential treatment selection markers: female age, ethnicity, smoking status, type of subfertility (primary/secondary), duration of subfertility, BMI, pre-wash total motile count and Hunault prediction score. For each potential treatment selection marker, we explored the association with the chances of a healthy child after IVF-SET and IUI-OS and tested if there was an interaction with treatment. Given the exploratory nature of our analysis, we used a P-value of 0.1. Main results and the role of chance None of the markers were associated with higher chances of a healthy child from IVF-SET compared to IUI-OS (P-value for interaction >0.10). Limitations, reasons for caution Since this is the first large study that looked at potential treatment selection markers for IVF-SET compared to IUI-OS, we had no data on which to base a power calculation. The sample size was limited, making it difficult to detect any smaller associations. Wider implications of the findings We could not identify couples with unexplained or mild male subfertility who would have had higher chances of a healthy child from immediate IVF-SET than from IUI-OS. As in the original trial IUI-OS had similar effectiveness and was less costly compared to IVF-SET, IUI-OS should remain the preferred first-line treatment in these couples. Study funding/competing interest(s) The study was supported by a grant from the Netherlands Organization for Health Research and Development, and a grant from the Netherlands' association of health care insurers. There are no conflicts of interest. Trial registration number The trial was registered at the Dutch trial registry (NTR939).
- Published
- 2017
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