Administration of a GnRH Antagonist During 3 Days at Initiation of the Cycle: Impact on the Stimulation in IVF/ICSI
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Endocrine profile
研究概览
简要总结
In this prospective study, the investigators would like to show whether ovarian stimulation with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle, is possible.
详细描述
A recently accepted study demonstrated that raised progesterone levels can be normalized through administration of a GnRH antagonist during three subsequent days prior to the start of gonadotropin stimulation in a GnRH antagonist protocol. This regimen, after normalisation of the progesterone value, allows controlled ovarian hyperstimulation (COH). Since this regimen is valid in case of elevated progesterone, GnRH antagonists pretreatment may prove to be a valid tool for scheduling IVF treatment in patients with normal progesterone values on day 2 of the cycle. In this prospective randomised trial, the investigators study the impact of administration of a GnRH antagonist during 3 consecutive days at initiation of the cycle.
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
- Single (Participant)
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
- •< 39 years old on day of randomisation
- •FSH < 12 (in the early follicular phase)
- •Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
- •Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
- •BMI between 18 and 29 (both inclusive)
- •1st or 2nd trial
- •IVF or ICSI
- •Randomisation at out-patient clinic
排除标准
- •≥ 39 years old on day of randomisation
- •Endometriosis ≥ grade 3
研究组 & 干预措施
A
Patients undergo a standard treatment with a classical GnRH antagonist protocol.
干预措施: ovarian stimulation (Drug)
B
Before undergoing a standard protocol for ovarian stimulation, patients in this group receive a pretreatment with GnRH antagonists during 3 consecutive days
干预措施: ovarian stimulation (Drug)
结局指标
主要结局
Endocrine profile
时间窗: up to 9 months
The purpose is to assess the endocrine profile in each treatment group
次要结局
- Pregnancy rate(up to 9 months)