Frozen-thawed Embryo Transfer in a Natural Versus Artificial Cycle: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate with fetal heart beat
研究概览
简要总结
This study evaluates clinical pregnancy rates, obstetrical outcome parameters, costs and patient preferences in natural cycle versus artificial cycle frozen embryo transfers (FET).
详细描述
Transfer of cryopreserved embryos can be performed in a natural cycle (NC-FET) or in an artificially prepared cycle (AC-FET). Both cycle regimens have their advantages and disadvantages. So far, most comparative studies have failed to identify the optimal protocol for FET. In this study patients undergoing FET will be randomized between an endometrial preparation by a natural cycle or by an artificial cycle (by oestradiol validate and micronized progesterone).
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing FET after a first, second or third fresh IVF/ICSI cycle
- •Single embryo transfer (SET) or Double embryo transfer (DET)
- •Female age between 18-45 year
- •Women having a natural ovulatory cycle (24-35 days)
- •Normal uterine cavity (fundal indentation at the cavity <10mm)
- •Written informed consent
排除标准
- •Use of donor gametes
- •BMI > or equal to 35 kg / m2
- •Any contra-indication to estrogen or progesterone supplementation (e.g. history of thrombosis, prior or current hormone-sensitive malignancy...)
研究组 & 干预措施
Natural cycle
no medication
干预措施: Natural cycle (Drug)
Artificial cycle
Oestradiol valerate (Progynova, Bayer, Germany) 6mg daily will be given from day 2 of the cycle. The dose of Progynova is increased to 8mg daily if the endometrial thickness is less than 7mm after 7-10 days of Progynova use. Progynova will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Progynova will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.
Micronized progesterone (Utrogestan, Besins, Belgium) 200 mg vaginally three times daily is started as soon as the endometrial thickness is 7 mm. Utrogestan will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Utrogestan will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.
干预措施: Estradiol Valerate (Drug)
Artificial cycle
Oestradiol valerate (Progynova, Bayer, Germany) 6mg daily will be given from day 2 of the cycle. The dose of Progynova is increased to 8mg daily if the endometrial thickness is less than 7mm after 7-10 days of Progynova use. Progynova will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Progynova will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.
Micronized progesterone (Utrogestan, Besins, Belgium) 200 mg vaginally three times daily is started as soon as the endometrial thickness is 7 mm. Utrogestan will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Utrogestan will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.
干预措施: Micronized progesterone (Drug)
结局指标
主要结局
Clinical pregnancy rate with fetal heart beat
时间窗: 9 weeks
Clinical pregnancy rate with fetal heart beat diagnosed by ultrasound no later than the gestational age of 9 weeks
次要结局
- Miscarriage rate(12 weeks)
- Biochemical pregnancy rate(9 weeks)
- Cycle cancellation rate(4 weeks)
- Multiple pregnancy rate(9 weeks)
- Ectopic pregnancy rate(9 weeks)
- Endometrial thickness(3 weeks)
- Live birth rate(41 weeks)
- Endometrial pattern(3 weeks)
- number of center visits to monitor FET cycle(From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks))
- cost analysis per treatment cycle(From date of randomization until the date of the embryo transfer or until cancellation (estimated period of time up to 4 weeks))
- patient satisfaction(12 weeks)
- Adverse events(12 weeks)