Pregnancy Clinical Trial
Official title:
A Randomized Controlled Comparison of Spontaneous Natural Cycles and Human Chorionic Gonadotrophin-induced Natural Cycles in Frozen-thawed Embryos Transfer
This is a randomized controlled trial on the comparison of the ongoing pregnancy rate in frozen-thawed embryo transfer cycles with spontaneous ovulation and hCG-induced natural cycles.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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