NCT03043924已完成不适用
Functional Study of the Hypothalamus in High-resolution Magnetic Resonance Imaging (MRI) in Women With Polycystic Ovary Syndrome (PCOS): a Comparative Study
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年9月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in the Apparent Diffusion Coefficient (ADC)
研究概览
简要总结
The aim to evaluate whether activation of the hypothalamic-pituitary-gonadal axis in PCOS is associated with transient microstructural and metabolic changes in the female hypothalamus using MRI approaches to assess water diffusion and measure proton magnetic resonance spectra.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For all subjects
- •Aged from 19 to 30 years
- •Body mass index : 18-25
- •Informed consent before inclusion
- •Do not smoke the 3 days before the MRI
- •For Healthy volunteers subjects :
- •Regular cycles (between 25 and 35 days) AND ovulatory.
- •No signs of hyperandrogenism.
- •Subjects desirous of taking oral contraceptives (estrogen/progestin combination).
- •For the realization of the 2nd MRI: to be during the 3rd month of a treatment well followed by oestro-progestative monophasic minidose to 0,02mg of Ethinyl-oestradiol / 0,1mg Levonorgestrel.
- •PCOS women:
- •PCOS defined by Rotterdam criteria
- •Needing a treatment with cyproterone acetate
- •To carry out the 2nd MRI: to be in progress during the 3rd month of a treatment well followed by 50 mg of Cyproterone acetate in association with 2mg / day of natural estradiol.
排除标准
- •Hormone treatment within 3 months prior to inclusion (including birth control pill )
- •On-going pregnancy (determined before each MRI scan visit)
- •Claustrophobia
- •Any metal or foreign implants (e.g., aneurysm clips, ear implants, heart pacemakers or defibrillators)
- •Diabetes or known dysthyroidism.
- •Current substance abuse (including smoking more than 5 cigarettes/day; determined using drug screening at the screening visit)
- •Pregnancy or breastfeeding the last 3 months.
- •Practice of intense physical exercise (ex jogging> 10km) the day before the MRI.
- •Person incapable of consenting, or enjoying legal protection (guardianship / curatorship).
- •Unability to understand the treatment protocol
研究组 & 干预措施
PCOS women
Other
26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited.
干预措施: Cyproterone Acetate + estradiol (Drug)
Healthy volunteers
Other
26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited.
干预措施: Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet (Drug)
结局指标
主要结局
Change in the Apparent Diffusion Coefficient (ADC)
时间窗: Baseline and 3 months after treatment start
The change in the ADC will be analyzed in healthy volunteers and PCOS women before starting the oral contraceptives, and next during the third sequence of treatment.
次要结局
- Change in the metabolite concentrations(Baseline and 3 months after treatment start)
- Correlation coefficient (Spearman or Pearson) between the ADC and serum hormonal levels (FSH,luteinizing hormone,oestradiol, AMH)(Baseline and 3 months after treatment start)
- Plasma GnRH concentration before and after treatment (PCOS patient and control group)(Baseline and 3 months after treatment start)
- Correlation coefficient (Spearman or Pearson) between the metabolite concentrations and serum hormonal levels (FSH, luteinizing hormone, oestradiol, AMH)(Baseline and 3 months after treatment start)
- Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception.(Baseline and 3 months after treatment start)
研究者
研究点 (1)
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