Abstract
BackgroundThe usefulness of hysterosalpingography (HSG) as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial.MethodsAll newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1 April 1997 and 31 December 1999, were eligible for the study. The reasons for non-participation were evaluated by scrutinizing the medical records.ResultsOut of 759 women, a total of 127 (17%) agreed to participate in the trial. The most important reason for non-participation was because of exclusion criteria (73%). Other reasons were inattentive clinicians (3%) and patient-associated reasons (24%). Patient refusal and indecisiveness to enroll in the study were the most common patient-associated reasons. The most frequently stated reason for trial refusal was reluctance to undergo laparoscopy and dye mainly due to issues related to anesthesia and scheduling of procedure.ConclusionAlmost three-quarters of recruitment difficulties in this study were due to unavoidable reasons. To overcome the remaining avoidable reasons for non-participation, attention should be paid to appropriate instruction of the study protocol to the participating doctors and to provide adequate information, in layman's terms, to the patients. Reminding patients by notes or telephone calls for attending the clinic are helpful. It may be contingent upon tracing the reasons of clinicians and patients for non-participation to improve enrollment during a trial.
Highlights
The usefulness of hysterosalpingography (HSG) as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial
If HSG showed normal uterine cavity, patent tubes and no tubal pathology, laparoscopy and dye followed after six months
This study identified potential eligible participants visiting one of the three participating hospitals (Leiden University Medical Centre) during the first half of the recruitment period
Summary
The usefulness of hysterosalpingography (HSG) as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. We estimated the highest recruitment rate from Leiden University Medical Centre (LUMC). About halfway through the trial, we had only recruited 177 women instead of an estimated 375. To understand this low recruitment rate, we initiated the current study to find strategies to avoid the major reasons for non-participation which could be implemented during the second half of the study or later in other studies in reproductive medicine. This study identified potential eligible participants visiting one of the three participating hospitals (Leiden University Medical Centre) during the first half of the recruitment period
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