IntroductionPolycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age and the leading cause of anovulatory infertility. Women with PCOS have a 15-fold higher prevalence of infertility, compared with women without PCOS, independent of body mass index (BMI). A healthy lifestyle is recommended to improve overall health and fertility in PCOS but there is limited evidence on the isolated effects of exercise, especially for reproductive outcomes. Previous findings indicate superior metabolic health benefits after vigorous compared with moderate-intensity exercise. Our primary aim is to determine the effect of high-intensity interval training (HIT) on menstrual frequency, as a proxy of reproductive function, in women with PCOS.Methods and analysisThe study is a two-centre, randomised, controlled trial with three parallel groups. Women (n=64) from Trondheim (Norway) and Melbourne (Australia) with PCOS according to the Rotterdam criteria will be randomly allocated (1:1:1) to high-volume HIT, low-volume HIT or a control group with no exercise after stratifying for BMI < or ≥ 27 kg/m2and study centre. Measurements for study end points will be undertaken at baseline, after a 16 week exercise intervention and at 12 months following baseline assessments. The primary outcome measure is menstruation frequency, measured as the number of self-reported menstrual bleedings divided by the number of expected menstrual bleedings during a 12-month period. Secondary outcome measurements include markers of cardiovascular, metabolic and reproductive health, as well as quality of life and adherence to and enjoyment of exercise.Ethics and disseminationThe Regional Committee Medical Research Ethics, Norway, and The Australian Catholic University Human Research Ethics Committee, Australia, have approved the trial protocol. This trial will provide new insight regarding the impact of exercise on fertility in PCOS. We expect this trial to contribute to new therapeutic exercise strategies as part of clinical care for women with PCOS.Trial registration numberClinical trial govNCT02419482.
OBJECTIVES:To investigate the intra-and inter-observer variation of the manual 3D Virtual Organ Computer-aided Analysis (VOCAL) in calculating fetal bladder volume and compare results from VOCAL with Sonography-based Automated Volume Count (SonoAVC) and a mathematical calculation based on three radiuses.
METHODS:Forty-five women attending the second trimester routine scan at St. Olavs Hospital, Trondheim, Norway were included in a prospective observational study. 3D acquisition of the fetal bladder was performed with Voluson E8 and the results were compared with intra-class correlation coefficient (ICC), repeatability coefficient and limits of agreement.
RESULTS:Good intra-observer agreement for both examiners was observed. ICCs were 0.98 and 0.99 and the repeatability coefficients were ± 27 and ± 25 mm 3 . However, we found a significant difference between the two observers. The mean difference was 20 mm 3 (95% CI 9-32). Inter-observer ICC was 0.96. The mean volume based on radiuses was 148 (SD 14) mm 3 vs. 145 (SD 14) mm 3 based on VOCAL and 161 (SD 16) mm 3 based on SonoAVC. The mean volume based on SonoAVC was significant larger than volumes based on radiuses. The ICCs between methods were good and varied from 0.82 to 0.93. The mean time used in calculating volumes was 94 seconds using VOCAL, 86 seconds using SonoAVC and 28 seconds calculating from radiuses.CONCLUSIONS: VOCAL and SonoAVC did not show advantages compared to calculations based on radiuses. Therefore, we recommend calculating volumes of spherical fetal organs from three radiuses because this method was easiest to perform.
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