SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Ongoing pregnancy
研究概览
简要总结
BACKGROUND: Despite the numerous advances in the field of in vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI), there still exists a maximum implantation rate per embryo transferred of about 30%. Next to the physiological and physic burden that comes with every IVF treatment cycle, implantation failure also adds up to the considerable costs associated with ART. Studies have shown, that minor intrauterine abnormalities can be found in 11-40% of the infertile women with a normal transvaginal sonography. Detection and treatment of these abnormalities by office hysteroscopy have led to a 9-13% increase in pregnancy rate. Therefore, it is increasingly advocated to screen all infertile women on intracavitary pathology prior to the start of IVF/ICSI.
OBJECTIVE: The aim of the proposed study is to assess whether diagnosing and treating unsuspected intrauterine abnormalities by saline infusion sonography and/or routine office hysteroscopy prior to a first IVF/ICSI treatment cycle improves the cost-effectiveness of the fertility treatment.
STUDY DESIGN: Multicenter randomized intervention study. POPULATION: Asymptomatic women, indicated for a first IVF/ICSI treatment cycle and a normal transvaginal ultrasonography.
INTERVENTION: Participants will be randomized for a (SIS and) hysteroscopy with treatment-on-the spot of predefined intrauterine abnormalities versus no diagnostic work-up. In both groups standard IVF/ICSI treatment will be initiated.
PRIMARY OUTCOME MEASURE:
Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
SECONDARY OUTCOME MEASURE:
- Cumulative implantation rate achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
- Cumulative miscarry rate within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
- Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment
- Patient preference and tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure
- Prevalence of unexpected intrauterine abnormalities
- Diagnostic accuracy of SIS in diagnosing intrauterine abnormalities
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women indicated for a first IVF/ICSI treatment
- •Primary or secondary infertility
- •Normal Transvaginal Ultrasound, performed in the follicular phase of the menstrual cycle
排除标准
- •Recurrent miscarriage
- •Prior hysteroscopy treatments
- •Meno-metrorrhagia (defined as any intermenstrual loss of blood)
结局指标
主要结局
Ongoing pregnancy
时间窗: 18 months
Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomisation (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
次要结局
- Costs(24 months)
- Implantation rate(18 months)
- Patient tolerance(24 months)
- Prevalence of unexpected intrauterine abnormalities(3 months)
- Miscarry rate(18 months)
- Diagnostic accuracy of SIS(3 months)