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Background: A physically active lifestyle is recommended to improve cardiometabolic health and fertility in women with polycystic ovary syndrome (PCOS), yet there are few randomized controlled trials investigating the effects of different exercise protocols on clinical reproductive outcomes. Our aim was to determine the effect of high-intensity interval training (HIT) on menstrual frequency, as a proxy of reproductive function, in women with PCOS. Methods: The IMPROV-IT study was a two-centre randomized controlled trial undertaken in Norway and Australia. Women with PCOS (Rotterdam criteria) were eligible for inclusion. After stratification for body mass index < or ≥27 kg/m2 and study centre, participants were randomly allocated by computer-generated random numbers (1:1:1) to high-volume HIT (HV-HIT), low-volume HIT (LV-HIT), or a control group. Measurements were assessed at baseline, after the 16-week exercise intervention and at 12-months follow-up. The primary outcome was menstrual frequency after 12 months. Secondary outcomes included markers of cardiometabolic and reproductive health, quality of life, and adherence to and enjoyment of HIT. Analysis was by intention-to-treat. Findings: The study took place between June 2015 and February 2020. We randomly allocated 64 participants to HV-HIT (n=20), LV-HIT (n=21), or the control group (n=23). There were no difference in menstrual frequency at 12 months between LV-HIT and control (frequency-ratio 0·09, 95%CI 0·06-0·12), HV-HIT and control (frequency-ratio 0·07, 95%CI 0·05-0·10) or LV-HIT and HV-HIT (frequency-ratio 0·09, 95%CI 0·07-0·13). More participants became pregnant in the LV-HIT group (n=5, 33·3%) than in the control group (n=0, p=0·02). Interpretation: HIT did not improve menstrual frequency in women with PCOS, but significantly increased pregnancy rate. Trial Registration: The study was registered in ClinicalTrials.gov (NCT02419482). Funding Statement: The Liaison Committee for Education, Research and Innovation in Central Norway, Norwegian University of Science and Technology, Australian Catholic University. Declaration of Interests: All authors declare no competing interests. Ethics Approval Statement: Ethics approval was obtained from the Regional Committee for Medical and Health Research Ethics in Central Norway (REK-midt 2015/468) and the ACU Human Research Ethics Committee (2017-260H). The procedures for data entry, coding, and storage have been approved by the Regional Committee Medical Research Ethics in Central Norway. All participants were informed about the experimental protocol and potential risks verbally and in writing before providing their written informed consent.

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.

Purpose To investigate the variability of the normal-sized fetal renal pelvis (≤5 mm) over time and to analyze repeatability of measurements. Materials and Methods 98 fetal renal pelvises and 49 fetal urinary bladders were analyzed at a gestational age of 17–20 weeks at St. Olavs Hospital, Trondheim, Norway. The anterior-posterior diameter (APD) of the fetal renal pelvis and two diameters of the fetal bladder were measured with an interval of at least 30 min. Intra- and interobserver variations and variations over time and in association with bladder size were investigated. Results The mean difference in renal pelvis size between the first and second measurements was 0.09 mm (95% CI, −0.09 to 0.26 mm). The variation over time was ≤1 mm in 85% of cases and the renal pelvis was ≤4 mm in both the first and second examinations in 92% of cases. The intraclass correlation coefficient (ICC) was 0.54 (95% CI: 0.31 to 0.69). We did not observe any association between variation of bladder size and variation of APD. The difference in fetal renal pelvis size was ≤1 mm in 70% of observations for the first examiner and 58% for the second examiner. The intraobserver ICCs were 0.71 (95% CI: 0.62–0.78) and 0.60 (95% CI: 0.50–0.70) for the two observers respectively. The interobserver difference was ≤1 mm in 72% of cases and the interobserver ICC was 0.56 (95% CI: 0.34–0.71). Conclusion The variation of the APD of the fetal renal pelvis over time was small in fetuses with the APD in the lower range and can mainly be explained by intraobserver variation. © Georg Thieme Verlag KG Stuttgart · New York. Published under a Creative Commons Attribution Non-Commercial No Derivatives License.

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.