ABSTRACT
BACKGROUND: Infertility affects 15%-25% of all couples during their reproductive life span. It is a significant societal and public health problem with potential psychological, social, and economic consequences. Furthermore, infertility has been linked to adverse long-term health outcomes. Despite the advanced diagnostic and therapeutic techniques available, approximately 30% of infertile couples do not obtain a live birth after fertility treatment. For these couples, there are no further options to increase their chances of a successful pregnancy and live birth. OBJECTIVES: Three overall questions will be studied: (1) What are the risk factors and natural life courses of infertility, early embryonic loss, and adverse pregnancy outcomes? (2) Can we develop new diagnostic and prognostic biomarkers for fecundity and treatment success? And (3) what are the health characteristics of women and men in infertile couples at the time of fertility treatment and during long-term follow-up? MATERIAL AND METHODS: ReproUnion Biobank and Infertility Cohort (RUBIC) is established as an add-on to the routine fertility management at Copenhagen University Hospital Departments in the Capital Region of Denmark and Reproductive Medicine Centre at Skåne University Hospital in Sweden. The aim is to include a total of 5000 couples equally distributed between Denmark and Sweden. The first patients were enrolled in June 2020. All eligible infertile couples are prospectively asked to participate in the project. Participants complete an extensive questionnaire and undergo a physical examination and collection of biospecimens (blood, urine, hair, saliva, rectal swabs, feces, semen, endometrial biopsies, and vaginal swabs). After the cohort is established, the couples will be linked to the Danish and Swedish national registers to obtain information on parental, perinatal, childhood, and adult life histories, including disease and medication history. This will enable us to understand the causes of infertility and identify novel therapeutic options for this important societal problem.
Subject(s)
Infertility , Prospective Studies , Reproductive Techniques , Adult , Biological Specimen Banks , Biomarkers/analysis , Denmark , Female , Fertility , Humans , Male , Pregnancy , Pregnancy Outcome , Risk Factors , SwedenABSTRACT
BACKGROUND: Recent findings from randomized clinical trials on the effects of hormone replacement therapy (HRT) among postmenopausal women contradict findings from observational studies indicating a protective effect on the development of cardiovascular disease. Most observational studies on HRT are based on self-reported data, although data on the validity of HRT in postmenopausal women are sparse. METHODS: We examined self-reported HRT use from questionnaires administered in 1993 (n = 2694) and again in 1999 (n = 2666) to a cohort of Danish nurses living in two Danish counties compared with prescription-reimbursement data from two administrative databases through the Danish National Health Service. RESULTS: The sensitivity and specificity of the self-reported, current HRT use in 1993 were 78.4%[95% confidence interval (95% CI) 75.4-81.4] and 98.4% (95% CI 97.8-98.9), respectively. In 1999, the estimates were 74.8% (95% CI 72.0-77.7) and 98.0% (95% CI 97.3-98.8), respectively. None of the factors examined--including age, alcohol intake, physical activity, smoking, presence of hypertension, and body mass index--was strongly associated with validity. We found a relatively high validity of self-reported data on HRT use. Furthermore, agreement between self-reported and registry-based data was not strongly associated with a range of demographic and lifestyle factors. CONCLUSION: These findings suggest that use of self-reported data is not an important contributor to the apparent discrepancy between observational studies and randomized trials on the cardiovascular effects of HRT use.
