The use of metformin and gonadotrophin-releasing hormone antagonist for the treatment of women with polycystic ovary syndrome undergoing in-vitro fertilisation embryo transfer: a single centre prospective double-blind randomised placebo-controlled trial

eeds Teaching Hospitals NHS Trust (UK)0 个研究点目标入组 200 人开始时间: 2009年6月25日最近更新: 2016年10月17日

适应症

试验速览

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•1. Women with a known diagnosis of PCOS (as defined by the Rotterdam European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine [ESHRE/ASRM] sponsored PCOS consensus workshop group, 2004)
•2. Women must have a normal serum follicular stimulating hormone (FSH) concentration (reference range 1 - 8.0 iU/L)
•3. Women must be 20 - 39 years of age
•4. Women must have a body mass index (BMI) less than or equal to 35 kg/m^2
•5. Pre-treatment inclusion criteria to include:
•5.1. Serum testosterone level less than 5.0 nmol/l
•5.2. Normal prolactin level (reference range less than 600 mU/L)
•5.3. Normal thyroid function test level (thyroid stimulating hormone [TSH] reference range 0.2 - 6.0 mIU/L)
•5.4. Normal renal, liver and haematological indices

•1. Women on other oral-antidiabetic agents or blood-glucose lowering preparations
•2. Women taking phenprocoumon
•3. Women taking antivirals such as didanosine, stavudine, tenofovir
•4. Women taking cimetidine
•5. Women taking ketofen
•6. Women who have radiological examinations using contrast media within the preceding 48 hours
•7. Women with renal or hepatic impairment
•8. Women who have had a recent myocardial infarct
•9. Women with known vitamin B12 deficiency

发起方

eeds Teaching Hospitals NHS Trust (UK)