A RCT Comparing Spontaneous Natural Cycles and Human Chorionic Gonadotrophin-induced Natural Cycles in FET
A Randomized Controlled Comparison of Spontaneous Natural Cycles and Human Chorionic Gonadotrophin-induced Natural Cycles in Frozen-thawed Embryos Transfer
研究概览
详细说明
Embryo cryopreservation is essential nowadays. It allows the usage of surplus good quality embryos in frozen-thawed embryo transfer (FET) cycles which avoids embryo wastage and facilitates the adoption of transferring a small number of embryos in the fresh stimulation cycle so as to reduce the risk of multiple pregnancy during in vitro fertilization (IVF) treatment. Elective cryopreservation of all fresh embryos is also required in special circumstances where fresh transfer is undesirable, for example in cases where a high risk of ovarian hyperstimulation syndrome is anticipated. Fresh transfer is not advisable when serum progesterone level is elevated or hydrosalpinx is detected during ovarian stimulation.
The availability of FETs would increase the likelihood of successful pregnancy from a single superovulation and oocyte retrieval cycle. It has been estimated that in modern IVF programmes which incorporates embryo cryopreservation, up to 42% of all conceptions could be derived from FET (Borini et al, 2008).
Although the pregnancy rate in FET is comparable with stimulated IVF cycles, the optimal regimen to prepare the endometrium for implantation is not yet well proven. By a recent Cochrane review, there is no evidence to prove the use of one regimen in preference to another (Ghobara T 2008).
Natural cycles (NC) are considered the best regimen as it is physiological, where natural conception occurs in. However, there are two most commonly employed methods to time the ovulation in natural cycles. One is to use ultrasound (USG) to monitor the follicular growth and endometrial thickness, with the use of human chorionic gonadotrophin (hCG) to trigger ovulation in the presence of a dominant follicle around 17-18mm in diameter. Another is to monitor the blood hormonal concentration to detect the luteinising hormone (LH) surge associated with natural ovulation. There is scarce information in this area as only one randomized controlled trial compared these two approaches. The authors aimed to recruit 240 subjects, but the study was prematurely terminated as significant results were resulted in the first interim analysis when the sample size reached 124. The ongoing pregnancy rate was 31.1% in the group with spontaneous LH surge and 14.3% in the hCG-induced group (Fatemi et al., 2010).
The use of natural LH surge and hCG trigger in intrauterine insemination was compared too. A meta-analysis revealed a significantly higher clinical pregnancy rate in IUI cycles with natural LH surge than that with hCG trigger. However, the data from randomized controlled trial showed no significant difference. Also the data were contradictory when the analysis confined to a specific indication of subfertility (Kosmas et al., 2007). A cochrane review in 2012 also suggested there was no evidence to advise that any regimen was better than another (Cantineau et al., 2012).
This randomized controlled trial aims to compare the ongoing pregnancy rate of FET in spontaneous NC and hCG-induced NC. The hypothesis of this trial is that the ongoing pregnancy rate of FET is similar for spontaneous NC and hCG-induced NC. The advantage of hCG-induced NC is likely a reduction in the duration of monitoring for timing FET when compared with spontaneous NC.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age of women <43 years
- Regular menstrual cycles ranging from 21-35 days with not more than 4 days variation between cycles
- Undergoing FET in natural cycles
- Normal uterine cavity as shown on saline sonogram performed before the IVF cycle or normal uterine cavity shown on pelvic scanning during the stimulated IVF cycle
- Endometrial thickness >=8mm in both stimulated IVF and FET cycles
Exclusion Criteria:
- >3 previous IVF cycles
- >6 embryos replaced without pregnancy
- Irregular menstrual cycles
- Subjects requiring clomid-induced cycles and hormonal replacement (HRT) cycles
- History of previous FET cycles within the study period
- Blastocyst transfer
- Preimplantation genetic diagnosis treatment
- Use of donor oocytes
- Presence of hydrosalpinx not corrected surgically prior to FET
- Recurrent miscarriage
- Serum progesterone level on the day of LH surge or day of hCG >5 nmol/L or 1.5 pg/L (these patients will be retrospectively excluded)
- Refusal to join the study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Spontaneous NC
Timing by the onset of LH surge as shown daily blood monitoring of serum estradiol and LH levels
|
ultrasound scanning would be carried out from 18 days before the expected period to confirm follicular growth, followed by daily blood monitoring of serum E2 and LH levels when the dominant follicle reaches 13-14mm in diameter.
Ultrasound scanning can be arranged accordingly if the leading follicle remains less than 10mm in diameter.
5 ml of blood would be taken daily.
LH surge is defined as the LH level being double of the average of the previous three days and higher than 20 IU/L.
Ultrasound examination will be performed on the next day after the LH surge to measure the endometrial thickness.
The transfer will be scheduled three or four days after the LH surge (for cleavage stage embryos) or six days after LH surge (for blastocyst transfer).
|
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实验性的:hCG induced NC
Timing by giving hCG when the dominant follicle reaches >=17mm in diameter on ultrasound monitoring
|
ultrasound monitoring would be started from 18 days before the expected period to monitor follicular growth, followed by USG every 2-3 days.
hCG, 5,000-10,000 IU will be given when the leading follicle is >/= 17 mm and the endometrium measures >/=8 mm.
Serum E2, LH and progesterone levels will be measured on the day of hCG.
Embryo transfer would be scheduled on the fourth or fifth days after hCG injection (for cleavage stage embryos) or seventh days (for blastocyst transfer).
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ongoing pregnancy rate
大体时间:12 weeks after embryos transfer
|
the ongoing pregnancy rate which is defined as the number of viable pregnancies beyond 10-12 weeks gestation per transfer cycle
|
12 weeks after embryos transfer
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Days of monitoring for timing FET
大体时间:4 weeks after last menstrual period
|
The number of days needed for the monitoring for the timing of FET
|
4 weeks after last menstrual period
|
|
Endometrial thickness on day of hCG or the next day after LH surge
大体时间:2-3 weeks after LMP
|
The measurement of the endometrial thickness on the day of hCG or the next day after LH surge
|
2-3 weeks after LMP
|
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Implantation rate
大体时间:4-6 weeks after embryo transfer
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Implantation rate: number of gestational sacs per number of embryos transferred
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4-6 weeks after embryo transfer
|
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pregnancy rate
大体时间:2-4 weeks after embryo transfer
|
number of positive pregnancy rate per transfer
|
2-4 weeks after embryo transfer
|
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Clinical pregnancy rate
大体时间:6-8 weeks after embryo transfer
|
Number of pregnancy with positive fetal pulsation on scanning at 6 weeks of gestation.
|
6-8 weeks after embryo transfer
|
|
Miscarriage rate
大体时间:20 weeks after embryo transfer
|
rate of pregnancy loss <20 weeks per transfer cycles
|
20 weeks after embryo transfer
|
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Multiple pregnancy rate
大体时间:20 weeks after embryo transfer
|
The rate of multiple pregnancy after ET
|
20 weeks after embryo transfer
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- HKU-VL-NChCGFET
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