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

Please cite this paper as: Boogaard N van den, Hompes P, Barnhart K, Bhattacharya S, Custers I, Coutifaris C, Goverde A, Guzick D, Litvak P, Steures P, Veen F van der, Bossuyt P, Mol B. 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. BJOG 2012;119:953–957. 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). Conclusion Ultimately, this study may help to select the appropriate fertility treatment, tailored to the needs of an individual couple.

Predicting live birth outcomes after in vitro fertilisation

“…We read with interest the article by van den Boogaard et al 1 that intends to perform an individual patient data (IPD) meta-analysis of subfertile couples and treatment outcomes using the Templeton model to estimate the chance of pregnancy after in vitro fertilisation (IVF). The model of Templeton et al analysed 36 961 treatment cycles undertaken in the UK between 1991 and 1994, and was validated in a population of 1253 couples receiving IVF treatment in the Netherlands between 1991 and 1999.…”

“…Sir, We thank Prof Nelson and colleagues 1 for their interest in our individual patient data (IPD) analysis, and for informing us about their prediction model to estimate the chance of pregnancy after in vitro fertilisation (IVF). The aim of our IPD analysis was to evaluate whether prognosis as predicted by a validated prediction model could be used for treatment selection in untreated couples with unexplained or mild male subfertility, i.e.…”

“…We read with interest the article by van den Boogaard et al 1 . that intends to perform an individual patient data (IPD) meta‐analysis of subfertile couples and treatment outcomes using the Templeton model to estimate the chance of pregnancy after in vitro fertilisation (IVF).…”

Association of uterine fibroids and pregnancy outcomes after ovarian stimulation–intrauterine insemination for unexplained infertility

“…In couples with unexplained infertility, who do not have an identifiable etiology for their inability to conceive, initial empirical treatment commonly involves ovarian stimulation with intrauterine insemination (OS-IUI) (21–23). It is estimated that approximately 10 to 50% of reproductive-aged women have uterine fibroids (24, 25) and an estimated 15% of infertile couples have unexplained infertility (6, 26). The Reproductive Medicine Network’s (RMN) Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) multicenter randomized clinical trial provides an opportunity to evaluate the relationship between non-cavity distorting fibroids and pregnancy outcomes in couples with unexplained infertility (27).…”

Intrauterine Insemination in Unexplained Female Infertility

“…In this group of patients is very difficult to quantify the appropriate number of IUI before proceeding to ART. In general, after four to six cycles of IUI in young patients it is appropriate to resort to ART [31]. Prognostic factors related to a higher cumulative pregnancy rate are duration of infertility less than 2 years, a previous pregnancy with the same partner and female age < 30 years.…”