A Randomized Controlled Trial of Clinical Effectiveness of Freezing All Embryos Followed by Frozen Thawed Embryo Transfer Compared to Fresh Embryo Transfer, in Women Undergoing In-vitro Fertilization Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
The objective of the present randomized controlled study is to compare clinical effectiveness and safety of freezing all embryos followed by frozen-thawed embryo transfer (FET) compared to fresh embryo transfer, in women undergoing IVF treatment.
详细描述
A total of 800 infertile women undergoing IVF treatment will be randomized into one of the following two groups by computer-generated random numbers:
Fresh embryo transfer group: a single fresh embryo transfer FET group: a single FET following freezing of all embryos in the stimulated IVF cycle
All techniques of IVF including ovarian stimulation, harvesting of oocytes, insemination with specially prepared sperm and embryo culture in the laboratory will be according to local protocols. Once the embryos have been cultured up to day 2 or 3, women with 3 or more suitable quality embryos will be randomized to either fresh embryo transfer (control arm) or FET (Intervention arm).
Control arm Women allocated to the control arm will either undergo embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols.
Intervention arm For those allocated to the intervention arm fresh embryo transfer will not be undertaken. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women under 42 years of age
- •Presence of at least 3 embryos suitable to freeze on day 2 or 3 following fertilisation based on the centre's criteria
- •Written informed consent
排除标准
- •Women using donor eggs/donor sperm
- •Women undergoing preimplantation genetic diagnosis
- •Women with abnormal uterine cavity shown on hysterosalpingogram or saline infusion sonogram
- •Women with hydrosalpinges shown on scanning and not corrected treated
- •Women with excessive ovarian response at risk of ovarian hyperstimulation where elective freeze is already planned
- •Women with serum progesterone level on day of human chorionic gonadotrophin>1.5ng/ml or 5 nmol/L
- •Women whose embryos have not survived freeze-thawing in the past
- •Fresh transfer is planned e.g. patients with endometriosis or adenomyosis who have received prolonged downregulation
- •Only frozen transfer is planned e.g. patients receiving ovarian stimulation regimens which may have adverse impacts on the endometrium
研究组 & 干预措施
Control arm
Women allocated to the control arm will either undergo fresh embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols.
干预措施: Fresh embryo transfer (Procedure)
Intervention arm
Fresh embryo transfer will not be undertaken in this group. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer.
干预措施: Frozen embryo transfer (Procedure)
结局指标
主要结局
Live birth rate
时间窗: up to 24 weeks
A baby born alive after 20 weeks gestation
次要结局
- Miscarriage rate(up to 24 weeks)
- Clinical pregnancy rates(up to 24 weeks)
- Failure of embryos to survive after thawing (per embryo thawed)(around 6 months)
- Complications of pregnancy(around 1 years)
- Ovarian hyperstimulation rate(about 1 month)
- Cumulative live birth within 6 months of ovarian stimulation(up to 24 weeks)