PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment
试验速览
- 阶段
- 4 期
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up
研究概览
简要总结
PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.
The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal
详细描述
PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.
The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal Ovarian drilling will be performed by FERTILOSCOPY. 126 patients will be necessary in each group (with interval of equivalence : 10%).
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
- None
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 36 years old
- •Female patient with PCOS (Rotterdam criteria)
- •Failure of treatment with Clomiphene Citrate
- •Informed consent
- •Female patient with medical assurance
- •Patient in failure with PCOS and Clomiphene citrate
排除标准
- •Female patient is over 36 years old
- •Thyroid disease (4<TSH<0.3 mUI/L)
- •Virilizing tumor
- •FERTILOSCOPY non possible (Douglas cul de sac clinically fixed)
- •Anormality of SPERMOGRAM (abnormal time of migration of survival)
- •Prolactin > 1.5 N
- •Anormality of 17-OH Progesterone (<2 ng/mL)
- •Fallopian tubes non permeable TMS< 5 Millions
- •Female patient participant or have been participated to another clinical trial during the last month before the inclusion
- •Female patient without medical assurance
研究组 & 干预措施
A
干预措施: Metformin and FSHr (Drug)
B
干预措施: Ovarian drilling by FERTILOSCOPY (Procedure)
结局指标
主要结局
Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up
时间窗: during 9 months of follow-up
次要结局
- Occurrence of multiple pregnancies(at the end of the study)
- Duration of the menstrual cycles and hormonal ovarian dosages(during the study)
- Occurrence of spontaneous miscarriages(at the end of the study)
- Evaluation of tolerance(during the study)
- Body Mass Index with each visit(at each visit)