Predictors of participant retention in infertility treatment trials

Abstract

Objective To identify variables associated with retention (or dropout) in infertility clinical trials. Retention of subjects in randomized controlled clinical trials (RCTs) has received considerable attention, but there have been few consistent findings. Design Secondary analysis of data from RCTs. Setting RCTs conducted by academic medical centers in the U.S. Patients Women with polycystic ovary syndrome or couples with unexplained infertility, 18–39 years of age. Interventions This study is not an intervention study, but the patients in the original RCTs were treated with any or combination of metformin, clomiphene citrate, letrozole, and gonadotropins. Main Outcome Measure Successful retention versus dropout during the RCTs. Results Race, ethnicity, BMI, insurance coverage, history of smoking, and history of alcohol use were significantly associated with retention whether they were considered in bivariate analyses or a multivariable logistic model. Specifically, white race, higher income, having graduate degrees, normal weight, better insurance coverage, non-smokers, and those who reported current use of alcohol at the start of the trial, had higher retention rates. Conclusion We identified several additive and persistent predictors of retention that can be used to guide the conduct of RCTs and improve the retention rate. Given the limitation of our association analysis, methodologically sound and theoretically grounded research are warranted so that high quality data can be collected to improve our understanding on the causes of dropout.

Licorice ethanol extract improves symptoms of polycytic ovary syndrome in Letrozole-induced female rats

“… 25 , 26 Hormonal contraceptives, selective estrogen receptor modulator (SERM), insulin sensitizers, gonadotropins, and ovarian surgery have been shown to be useful for improving PCOS symptoms in women. 22 , 27 , 28 These treatment approaches address a variety of PCOS symptoms, although current PCOS treatments are not successful in all phases of irregular ovarian function. 22 , 27 , 28 …”

“… 22 , 27 , 28 These treatment approaches address a variety of PCOS symptoms, although current PCOS treatments are not successful in all phases of irregular ovarian function. 22 , 27 , 28 …”

Factors associated with study protocol adherence and bio banking participation in reproductive medicine clinical trials and their relationship to live birth

“…Although several studies in other specialties, such as cervical cancer and hypertension research, have examined various strategies to improve retention and adherence to clinical trials in general (Grant and DePew, 1999;Shumaker et al, 2000;Bailey et al, 2004), only a few have evaluated factors that predict retention and adherence in clinical trials including race, ethnicity, socio-economic status and sex, and these have had varying results (Moore, 1997;Gorelick et al, 1998;Bowen et al, 2000). Non-adherence to study protocol in trials involving infertile women may include failure to attend critical study visits, take the assigned medication (McGovern et al, 2008) maintain a prescribed schedule of timed intercourse (Pagidas et al, 2010), and continue participation and follow-up (Kuang et al, 2015). Identifying factors that predict overall non-adherence to study protocol, and the effect of non-adherence upon the primary study outcomes, may help to underscore the importance of adherence, and lead to development of targeted strategies to facilitate adherence to protocol.…”

“…Race, ethnicity, BMI, insurance coverage and history of smoking or alcohol use previously have been shown to be predictors of study retention and dropout in Reproductive Medicine Network (RMNs) trials involving women with infertility (Kuang et al, 2015). While medication adherence (McGovern et al, 2008) and intercourse compliance (Pagidas et al, 2010) as individual factors did not affect pregnancy rates, the effect of a composite non-adherence to a study protocol, that includes all these factors, on the outcome of interventional trials in infertile women has not been previously evaluated.…”

The significant impact of education, poverty, and race on Internet-based research participant engagement

“… 5 By contrast, clinical studies have found that study engagement and retention are low among underserved populations, including African Americans and individuals without a high school education. 6 , 7 …”