Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 552
- 试验地点
- 2
- 主要终点
- Multiple pregnancy rate
研究概览
简要总结
Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Even if several first-step treatments have been proposed for anovulatory infertile PCOS patients, very few data are available in literature regarding the best integrated strategy. In fact, a single compound could be effective as first-step approach but not or less useful when integrated in a more complex strategy.
The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate.
详细描述
All patients eligible will undergo baseline assessment consisting of antropometric, hormonal, and ultrasonographic assessments. Successively, patients enrolled will be allocated in three different strategies (strategy A, B, and C).
A total of 184 infertile PCOS patients per arm will be enrolled and treated with three different integrated strategies: clomiphene followed by clomiphene plus metformin followed by gonadotropins (strategy A); metformin followed by metformin plus clomiphene followed by gonadotropins(strategy B); and metformin plus clomiphene followed by gonadotropins(strategy C).
In all patients, the same regimen will be used to administered clomiphene, metformin, and gonadotropins.Both clomiphene and metformin will be administered at incremental doses in each case.Gonadotropins will be administrated to obtain a controlled ovarian stimulation using highly purified urinary FSH in a low-dose step-up protocol.
During the study, the clinical and reproductive outcomes, and adverse experiences will be evaluated in each woman.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Polycystic ovary syndrome (using ESHRE/ARSM 2004 criteria)
排除标准
- •Age <18 or >35 years
- •Severe obesity (BMI >35)
- •Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
- •Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
- •Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs
- •Previous use of ovulation induction agents
- •Intention to start a diet or a specific program of physical activity
- •No uterine bleeding after progesterone challenge test
- •Organic pelvic diseases
- •Previous pelvic surgery
- •Suspected peritoneal factor infertility
- •Tubal or male factor infertility or sub-fertility
研究组 & 干预措施
Strategy A
clomiphene followed by clomiphene plus metformin followed by gonadotropins
干预措施: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins (Drug)
Strategy B
metformin followed by metformin plus clomiphene followed by gonadotropins
干预措施: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins (Drug)
Strategy C
metformin plus clomiphene followed by gonadotropins
干预措施: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins (Drug)
结局指标
主要结局
Multiple pregnancy rate
时间窗: 9 months
次要结局
- Ovulation rate(15 months)
- Pregnancy rate(15 months)
- Abortion rate(15 months)
- Live-birth rate(24 months)
- Adverse-events(15)
研究者
Stefano Palomba
Associate Professor
University Magna Graecia