title: 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.
abstract: OBJECTIVE
  The current evidence concerning the best treatment option for couples with unexplained and male subfertility is inconclusive. Most studies that have evaluated the effectiveness of treatment options, such as expectant management (EM), intrauterine insemination (IUI), with or without controlled ovarian stimulation (COS), and in vitro fertilisation (IVF), have not taken the couples' prognosis into account. It is very likely that the individual prognosis of the couple influences the effect of treatment. Individual patient data analyses allow us to take these prognostic factors into account, and to evaluate their effect on treatment outcome. This study aims to use anonymised data from relevant published trials to perform an individual patient data meta-analysis, evaluating the effect of couples' prognosis on the effectiveness of EM, IUI, with or without COS, and IVF.
  
  
  METHODS
  Based on earlier systematic reviews and an updated search, randomised controlled trials will be considered for inclusion. Untreated subfertile couples with unexplained or male subfertility included in trials comparing EM, IUI, with or without COS, and IVF are included. Authors of the included studies will be invited to share their original anonymised data. The data will be assessed on validity, quality and completeness. The prognosis of the individual couple will be calculated with existing prognostic models. The effect of the prognosis on treatment outcome will be analysed with marker-by-treatment predictiveness curves, illustrating the effect of prognosis on treatment outcome. This study is registered in PROSPERO (registration number CRD42011001832).
  
  
  CONCLUSIONS
  Ultimately, this study may help to select the appropriate fertility treatment, tailored to the needs of an individual couple.
authors.affiliation: Centre for Reproductive Medicine, Academic Medical Centre (AMC), Amsterdam, The Netherlands. n.m.vandenboogaard@amc.uva.nl
authors.forename: N M
authors.initials: NM
authors.lastname: van den Boogaard
authors.forename: P G A
authors.initials: PG
authors.lastname: Hompes
authors.forename: K
authors.initials: K
authors.lastname: Barnhart
authors.forename: S
authors.initials: S
authors.lastname: Bhattacharya
authors.forename: I M
authors.initials: IM
authors.lastname: Custers
authors.forename: C
authors.initials: C
authors.lastname: Coutifaris
authors.forename: A J
authors.initials: AJ
authors.lastname: Goverde
authors.forename: D S
authors.initials: DS
authors.lastname: Guzick
authors.forename: P F
authors.initials: PF
authors.lastname: Litvak
authors.forename: P N
authors.initials: PN
authors.lastname: Steures
authors.forename: F
authors.initials: F
authors.lastname: van der Veen
authors.forename: P
authors.initials: P
authors.lastname: Bossuyt
authors.forename: B W J
authors.initials: BW
authors.lastname: Mol
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D011247:Pregnancy; D005307:Fertilization in Vitro / Q000379:methods; D007247:Infertility, Female / Q000628:therapy; D007248:Infertility, Male / Q000628:therapy; D007315:Insemination, Artificial / Q000379:methods; D015201:Meta-Analysis as Topic; D010062:Ovulation Induction / Q000379:methods; D011256:Pregnancy Outcome; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome