Timed Intercourse Versus Intrauterine Insemination in Infertile Patients Undergoing Gonadotropin Ovarian Stimulation
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
At the present the first options to induce ovulation in polycystic ovary syndrome with anovulatory infertility are clomiphene citrate (CC) and metformin. Notwithstanding the effectiveness of CC and metformin alone or in a sequential or combined regimen, a percentage of patients ranging from 5% to 30% remain anovulatory. For these patients, the use of gonadotropins for controlled ovarian stimulation (COS) is indicated.
Moreover, to date it isn't clear if COS should be followed by timed intercourse (TI) or intrauterine insemination (IUI).
The aim of the present study will be to compare TI and IUI in infertile PCOS patients undergoing COS in terms of cost-benefit.
详细描述
Infertile PCOS patients who remain anovulatory after CC or metformin treatment will be enrolled. All patients will receive gonadotropins in low-dose step-up protocol for COS, and randomized to receive three trials of TI (group A) or IUI (group B).
All patients eligible will undergo baseline assessment consisting of anthropometric, hormonal, and ultrasonographic evaluations.
In all patients the COS will be obtained using highly purified urinary FSH in a low-dose step-up protocol, and both TI and IUI will be performed after 35 hours from ovulation induction with human chorionic gonadotropin.
During the study, the clinical and reproductive outcomes, the adverse experience will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant. Continuous variables will be analyzed with the unpaired t test and general linear model for repeated measures analysis with Bonferroni test for the post-hoc analysis as required. For categorical variables, the Pearson chi-square and Fisher's exact tests will be used. Cumulative pregnancy rate, our primary end-point, will be calculated by the Kaplan-Maier method, and the differences between the two groups will be assessed with the log-rank test. Cox proportional-hazards model will be used to calculate the hazard ratio for new pregnancy in both groups.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Polycystic ovary syndrome (using NIH criteria)
- •Anovulatory infertility (using WHO 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, anti-obesity drugs, hormonal drugs
- •Intention to start a diet or a specific program of physical activity
- •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
Group A
COS followed by TI
干预措施: timed intercourses, intrauterine insemination (Behavioral)
Group A
COS followed by TI
干预措施: highly purified urinary FSH (Drug)
Group B
COS followed by IUI
干预措施: highly purified urinary FSH (Drug)
Group B
COS followed by IUI
干预措施: timed intercourses, intrauterine insemination (Behavioral)
结局指标
主要结局
Pregnancy rate
时间窗: 3 months
次要结局
- Abortion rate(3 months)
- Adverse events(3 months)
- OHSS(3 months)
- Multiple pregnancy rate(3 months)
- Costs(3 months)
研究者
Stefano Palomba
Associate Professor
University Magna Graecia