Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,099
- 试验地点
- 2
- 主要终点
- Frequency of Ovarian Hyperstimulation Syndrome (OHSS)
研究概览
简要总结
Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to
- frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure)
- quality of life (2. outcome measure)
- live birth rate (2. outcome measure)
- gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol and vascular endothelial growth factor in follicular fluid(not only compared between GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS and patients becoming pregnant and not becoming pregnant (2. outcome measure), and
- number of oocytes removed per treatment, number of embryo transfers per treatment and number of spontaneous abortions per treatment (these three parameters are tertiary outcome measures).
In addition to the above mentioned efficacy outcome measures the safety outcome measure "frequency of known side-effects" will be compared between the two protocols.
详细描述
Patients: 1100 patients are randomized prospectively to either treatment. Stratification: =<36 y/>36 y, IVF/ICSI, and treatment centre.
Methods: OHSS is quantified by consecutive measurements of weight, abdominal diameter, ultrasound measurements of ascites and ovarian volume, paraclinical parameters, and by a systematic patient questionnaire. Furthermore it is registered if the patients have been hospitalized and/or have had ascites drainage performed due to OHSS. Data from the first 100 patients are used together with Golans OHSS-classification, to make a more precise definition of OHSS. This definition is applied prospectively on data from the remaining patients.
Quality of life is gauged by a questionnaire. Child birth rate is ascertained by a pregnancy response questionnaire and by obtaining data from the Danish National Birth Registry.
Statistics: The study is designed to be able to show a 50% reduction of OHSS comparing short to long protocol.
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients referred for infertility receiving their first IVF or IVF+ICSI treatment
排除标准
- •Previous IVF or IVF+ICSI-treatment
- •Uterine anomalies
- •It is necessary to perform direct sperm aspiration from husband's/partner's testicles
- •Allergy to one of the intervention products
- •Patient is 40 years or above
研究组 & 干预措施
1
Patients receiving short protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-antagonist (Orgalutran®: Ganirelix)
干预措施: Patients receiving short protocol IVF/ICSI-treatment. (Drug)
2
Patients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®: Nafarelin)
干预措施: Long protocol (Drug)
结局指标
主要结局
Frequency of Ovarian Hyperstimulation Syndrome (OHSS)
时间窗: 3 years
次要结局
- Live births(3 years)
- Gene expression profiles of granulosa and cumulus cells(3 years)
- Estradiol and vascular endothelial growth factor concentrations in follicular fluid.(3 years)
- Quality of life during treatment(3 years)
研究者
Peter Hornnes, MD, DMSc
MD, DMSc
Hvidovre University Hospital