ABSTRACT
INTRODUCTION: Low vitamin D status is prevalent among women with polycystic ovary syndrome (PCOS). The objective of the study is to assess the effect of vitamin D supplementation on (1) the ovulation rate to letrozole and (2) other reproductive, endocrine and metabolic outcomes after 1 year of supplementation in women with PCOS. METHODS AND ANALYSIS: This is a multicentre, randomised, double-blind, controlled clinical trial. A total of 220 anovulatory women with PCOS diagnosed by the Rotterdam criteria will be recruited. They will be randomly assigned to either the (1) vitamin D supplementation group or (2) placebo group. Those in the vitamin D group will take oral Vitamin D3 50 000 IU/week for 4 weeks, followed by 50 000 IU once every 2 weeks for 52 weeks. Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5 mg to 7.5 mg for 5 days per cycle titrated according to response) for ovulation induction. The primary outcome is the ovulation rate. All statistical analyses will be performed using intention-to-treat and per protocol analyses. ETHICS AND DISSEMINATION: Ethics approval was sought from the Institutional Review Board of the participating units. All participants will provide written informed consent before joining the study. The results of the study will be submitted to scientific conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04650880.
Subject(s)
Letrozole , Ovulation Induction , Ovulation , Polycystic Ovary Syndrome , Adult , Female , Humans , Young Adult , Aromatase Inhibitors/therapeutic use , Aromatase Inhibitors/administration & dosage , Dietary Supplements , Double-Blind Method , Letrozole/therapeutic use , Letrozole/administration & dosage , Multicenter Studies as Topic , Ovulation/drug effects , Ovulation Induction/methods , Polycystic Ovary Syndrome/drug therapy , Polycystic Ovary Syndrome/complications , Randomized Controlled Trials as Topic , Vitamin D/therapeutic use , Vitamin D/administration & dosageABSTRACT
OBJECTIVE. To investigate the clinical efficacy and safety of irreversible electroporation for ablation of liver tumour in humans. DATA SOURCES. The PubMed and MEDLINE databases were systematically searched. STUDY SELECTION. Clinical research published in English in the last 10 years until October 2013 that address clinical issues related to irreversible electroporation of human liver tumours were selected. "Liver tumor", "local ablative therapy", and "irreversible electroporation" were used as the search terms. DATA EXTRACTION AND SYNTHESIS. The data extracted for this review was analysed by the authors, with a focus on the clinical efficacy and the safety of irreversible electroporation. The complete response rates look promising, ranging from 72% to 100%, except in one study in a subgroup of liver tumours in which the complete response rate was only 50% that was likely due to the inclusion of larger-size tumours. In one study, the local recurrence rate at 12 months was approximately 40%. As for the safety of irreversible electroporation, there were only a few reported complications (cardiac arrhythmia, pneumothorax, and electrolyte disturbance) that were mostly transient and not serious. There was no reported mortality related to the use of irreversible electroporation. CONCLUSION. Irreversible electroporation is a potentially effective liver tumour ablative therapy that gives rise to only mild and transient side-effects. Further studies with better patient selection criteria and longer follow-up are needed to clarify its role as a first-line liver tumour treatment modality.
