Abstract STUDY QUESTION Does processing of spermatozoa for IVF with ICSI by a microfluidic sperm separation device improve embryo quality compared with density-gradient centrifugation? SUMMARY ANSWER Patients randomized to microfluidic sperm preparation had similar cleavage- and blastocyst-stage embryo quality and clinical and ongoing pregnancy rates to those who underwent standard sperm processing for IVF with ICSI. WHAT IS KNOWN ALREADY Microfluidic sperm preparation can isolate spermatozoa for clinical use with minimal DNA fragmentation but with unclear impact on clinical outcomes. STUDY DESIGN, SIZE, DURATION A prospective randomized controlled trial of 386 patients planning IVF from June 2017 through September 2021 was carried out. PARTICIPANTS/MATERIALS, SETTING, METHODS One hundred and ninety-two patients were allocated to sperm processing with a microfluidic sperm separation device for ICSI, while 194 patients were allocated to clinical standard density-gradient centrifugation (control) at an academic medical centre. MAIN RESULTS AND THE ROLE OF CHANCE In an intention to treat analysis, there were no differences in high-quality cleavage-stage embryo fraction [66.0 (25.8)% control versus 68.0 (30.3) microfluidic sperm preparation, P = 0.541, absolute difference −2.0, 95% CI (−8.5, 4.5)], or high-quality blastocyst fraction [37.4 (25.4) control versus 37.4 (26.2) microfluidic sperm preparation, P = 0.985, absolute difference −0.6 95% CI (−6, 5.9)] between groups. There were no differences in the clinical pregnancy or ongoing pregnancy rates between groups. LIMITATIONS, REASONS FOR CAUTION The population studied was inclusive and did not attempt to isolate male factor infertility cases or patients with a history of elevated sperm DNA fragmentation. WIDER IMPLICATIONS OF THE FINDINGS Microfluidic sperm separation performs similarly to density-gradient centrifugation in sperm preparation for IVF in an unselected population. STUDY FUNDING/COMPETING INTEREST(S) No external funding to declare. M.P.R. is a member of the Clinical Advisory Board for ZyMōt® Fertility, Inc. TRIAL REGISTRATION NUMBER NCT03085433. TRIAL REGISTRATION DATE 21 March 2017. DATE OF FIRST PATIENT’S ENROLLMENT 16 June 2017.
2035 Background: BAY 43–9006 is an orally available inhibitor of Raf kinase that has also been shown to inhibit angiogenesis in tumor xenografts. In a clinical trial of BAY 43–9006, we observed elevated blood pressure (BP), commonly associated with angiogenesis inhibitors. We investigated the mechanism of BP elevation in patients treated with BAY 43–9006. Methods: Twenty patients (13 males and 7 females, age range 32–83, median 59, PS 0–1) were treated with BAY 43–9006 400 mg orally twice daily. Aldosterone, catecholamines, endothelin, urotensin II, serum VEGF and von Willebrand factor (vWf), all factors shown to be mediators of vascular tone and hypertension, were measured at baseline and after three weeks of therapy. Tumor blood flow and vascular permeability were measured by DCE-MRI, and left ventricular ejection fraction and pulmonary artery systolic pressure by echocardiogram. Aortic pulse wave velocity (PWV), aortic augmentation index (AIX) were performed at baseline and after three weeks of therapy. Results: 19 patients are evaluable for BP, serologic and cardiologic evaluations, and 3 patients are evaluable for response. 11 of 19 (58%) (p<0.001) patients experienced an increase of 20 mmHg or more in systolic BP compared to their baseline value after 3 weeks of beginning BAY 43–9006 and BP remained elevated at 6 weeks. The mean increase of BP for all patients was 20 mmHg (±17, s.d.). Increased serum VEGF was observed in 9 of 13 evaluable patients, but did not correlate with BP elevation. Total catecholamines were decreased in 8 of 11 patients with elevated BP. PWV and AIX increased from 8.7 to 9.6 m/sec and from 21% to 30% respectively (P=NS). All 3 patients evaluable for response achieved PR and 2 of these patients experienced an increase of BP. Conclusions: Mild hypertension occurs with BAY 43–9006 treatment, and may be associated with changes in catecholamines and with indices of vascular stiffness. No significant financial relationships to disclose.
Obstructed hemivagina and ipsilateral renal anomaly (OHVIRA) syndrome is a rare complex of structural abnormalities of the female urogenital tract. A 17-year-old girl with uterine didelphys associated with OHVIRA syndrome presented with progressive development of cyclic lower abdominal discomfort and a large abdominopelvic mass. We describe the findings from ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI), the first case report of this syndrome to examine all three different imaging modalities in a single patient. We also review the literature on OHVIRA syndrome and discuss important considerations relevant to radiologists and other clinicians.
