Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women
研究概览
简要总结
Aim of study: To investigate whether four months of metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical pregnancy rate in normal-weight (body mass index [BMI] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women.
详细描述
PCOS is an hormonal disease including hyperandrogenism, oligo-or anovulation and/or polycystic ovaries by ultrasound. PCOS women often suffer insulin resistance or even diabetes risk as well as a full blown metabolic disease.
These women often suffer infertility due to their lack of regular ovulations. Metformin is a well known anti-diabetic drug, and in some PCOS women metformin might decrease the hyperandrogenism, improve insulin resistance and give more regular ovulations. Thereby increase chance of pregnancy. Our hypothesis is that metformin will increase clinical pregnancy rates both spontaneously and following IVF/ICSI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Fulfilling Rotterdam criteria for PCOS
- •Infertility more than 1 year
- •First or second cycle of IVF/ICSI treatment
- •Age below 38 years at inclusion
- •BMI below 28 kg/m3 at inclusion
- •Willing to be randomised to 4 months metformin or placebo
- •Signed written informed consent
排除标准
- •Not suitable for starting dose 112.5 IE
- •Basal FSH above 10 IU/L
- •Known renal disease or s-creatinine above 110 umol/L
- •Known liver disease or s-ALAT above 80 IU/L
- •Known alcoholism or drug abuse
- •Known diabetes mellitus or fasting plasma glucose above 7 mmol/L
- •Corticosteroid treatment (oral)
- •Treatment with cimetidine, anticoagulants, erythromycin or other macrolides
- •Hyperprolactinemia (PRL above 700 mIU/L)
- •Abnormal thyroid function tests
- •Known congenital adrenal hyperplasia
- •Androgen secreting tumours
- •Cushing syndrome
- •Metformin treatment within the last one month prior to screening
- •Unfit to participate for any other reason
研究组 & 干预措施
M: Metformin P: Placebo
干预措施: Metformin / Placebo treatment for 4 months (Drug)
结局指标
主要结局
To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women
时间窗: Vaginal ultrasound in pregnancy week 7
次要结局
- Spontaneous pregnancy rates during the pretreatment period, Spontaneous abortion rates (I or II trim.abortions), Live birth rates,(Vaginal ultrasound in pregnancy week 7)
- Number of oocytes collected, Embryo quality, Number of days of gonadotrophin treatment, Dose of gonadotrophin, total per cycle and daily, s-estradiol on day of hCG-administration, Occurrence of ovarian hyperstimulation syndrome (OHSS)(All data evaluated at study end, from september 2009 onwards)