Hysteroscopy Before in Vitro Fertilization - Does it Improve the Outcome?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- pregnancy rates
研究概览
简要总结
By randomizing sub-fertile women to either control or office-hysteroscopy in the circle prior to IVF or ICSI (intracytoplasmatic sperm injection
) treatment, we aim to enlighten whether hysteroscopy with endometrial biopsy increases pregnancy rates in the intervention group.
详细描述
Background A tenth of a population in Denmark today is the result of assisted fertility, including IVF and ICSI. In roughly 40 % of these subfertile women the reason is unknown. Standard initial procedures include transvaginal ultrasonography, with or without saline infusion to detect intrauterine abnormalities that might explain the infertile condition. The golden standard to detect intrauterine abnormalities is hysteroscopy. Such abnormalities can be detected in a fourth of this population. Earlier studies indicate that the hysteroscopy alone - without correcting any abnormalities, affects IVF/ISCI outcome positively.
Aim By randomizing patients referred to the fertility clinic to ±office-hysteroscopy in circle prior to IVF/ISCI, we aim to enlighten whether mini-hysteroscopy with endometrial biopsy will increase the fertility by looking at pregnancy rates as our main outcome.
Method Women signed up for second IVF/ISCI treatment will be recruited, after signed consent they are randomized to either office-hysteroscopy or nothing before standard treatment in the fertility clinic.
Mini-hysteroscopy is a standard procedure in our gynecological outpatient clinic. The procedure is done without any anesthetics. Only women with normal intrauterine conditions will be enrolled in this protocol.
When the fertility clinic has a positive serum-HCG (human chorionic gonadotropin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women submitted to IVF or ISCI treatment
- •Age > 18 years
- •Women able to read, speak and understand Danish
- •Written consent
排除标准
- •Intrauterine abnormalities
- •Infection
- •BMI > 35
- •Known intrauterine cause to the infertile condition
- •Abuse of alcohol or drugs
- •Untreated medical condition
- •Pregnancy
结局指标
主要结局
pregnancy rates
时间窗: individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years.
Positive serum HCG and transvaginal ultrasonography, alternatively negative serum HCG and negative outcome will be registrated. After 300 women have been included final outcome will be evaluated.
次要结局
未报告次要终点
研究者
Kristine Juul Hare
PhD, MD
Hvidovre University Hospital