Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
- Conditions
- Infertility
- Interventions
- Procedure: blastocyst-stage embryo transferProcedure: cleavage-stage embryo transfer
- Registration Number
- NCT03152643
- Brief Summary
The aim of this RCT is to compare differences in the efficacy and safety between cleavage-stage embryo transfer and blastocyst-stage embryo transfer in IVF/ICSI treatment cycle, taking into account of subsequent vitrified embryo transfers. Subjects with 3 or more transferrable cleavage embryos will be randomized to the cleavage-stage or blastocyst-stage embryos transfer group. The primary outcome is cumulative live birth rate (CLBR) per patient until the first live birth from one initiated oocyte retrieval cycle, calculated using outcomes from the first three embryo transfers within 1 year after randomization.
- Detailed Description
This is a multicenter, randomized clinical trial comparing the efficacy and safety between cleavage-stage embryo transfer and blastocyst-stage embryo transfer in IVF/ICSI treatment cycle, taking into account of subsequent vitrified embryo transfers.Randomization will be performed on day 2/3 after oocyte retrieval, when at least 3 embryos are achieved. Patients in group A will have 1 cleavage-stage embryo transferred. Patients in group B will have 1 blastocyst-stage embryo transferred. The outcomes from all the embryo transfers within 1 year after randomization will be followed up. If a pregnancy/live birth is not achieved, single embryo transfer is required for the first 3 embryo transfers within 1 year after randomization. For embryo transfers beyond the third within the 1 year, patient's treatment must follow their randomized allocation, and SET is no longer mandatory. The follow-up period is 2 years from the day of randomization.Due to the COVID-19 pandemic, the participants who were unable to undergo the embryo transfers in 1 year of randomization will have 3 months extension for frozen embryo transfer. The follow-up for these participants will be extended for 3 months as well.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 992
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description blastocyst-stage embryo transfer group blastocyst-stage embryo transfer For subjects assigned to blastocyst-stage (D5/D6) embryo transfer group, all embryos will be cultured to D5 or D6. 1 blastocysts of the best quality will be transferred in fresh cycle on D5 or D6 after oocyte retrieval (D5 embryo will be the prior choice). The surplus embryos, if any, will be vitrified for future FET in case the fresh cycle does not result in a live birth. If a patient is at a high risk of OHSS, all embryos on D5 or D6 can be cryopreserved with vitrification for patient's safety. The FET cycle will be initiated on the second menstrual cycle after oocyte retrieval. cleavage-stage embryo transfer group cleavage-stage embryo transfer For subjects assigned to the cleavage-stage (D2/3) embryo transfer group, 1 cleavage embryos of the best quality will be transferred in fresh cycle on Day 2/3 after oocyte retrieval. The surplus embryos, if any, will be vitrified for future FET if the fresh cycle does not result in a live birth. If a patient is at a high risk of OHSS, all embryos on Day 2/3 are allowed to be cryopreserved with vitrification for patient's safety. The FET cycle will be initiated on the second menstrual cycle after oocyte retrieval.
- Primary Outcome Measures
Name Time Method cumulative live birth rate 30 months Cumulative live birth rate (CLBR) is defined the first live birth per patient from one initiated oocyte retrieval cycle(Calculated using outcomes from the first three embryo transfers within 1 year after randomization). Live birth is defined as delivery of any neonate ≥24 weeks gestation with heart beat and breath.
- Secondary Outcome Measures
Name Time Method congenital anomalies 30 months structural or functional anomalies that occur during intrauterine life and can be identified prenatally, at birth or later in life.
Birth weight 30 months Weight of newborns at delivery
moderate or severe OHSS rate 12 months Number of patients with moderate or severe OHSS/ number of COS cycles.
ectopic pregnancy 24 months diagnosed by ultrasound examination or laparoscopic surgery visualizing more than or equal to 1 gestational sacs outside the uterus or by abnormally increasing serum hCG level without sonographic visualization and the absence of chorionic villi inside the uterus after uterine curettage, which was treated by methotrexate.
incidence of obstetric and perinatal complications 30 months Number of pregnancies with complications / number of pregnancies; ;number of live births with neonatal complications / number of live births
clinical pregnancy rate 30 months Clinical pregnancy is defined by the presence of intrauterine gestation sacs at 30-35 days after embryo transfer.
ongoing pregnancy rate 30 months Ongoing pregnancy is defined as a viable pregnancy at 12 weeks gestation.
Pregnancy loss rate 30 months Pregnancy loss is defined as a pregnancy that results in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.
biochemical pregnancy rate 30 months Biochemical pregnancy is defined as a serum β-HCG level of at least 25 IU/L 14 days after embryo transfer.
sex ratio 30 months the ratio of males to females in the newborns
multiple pregnancy 30 months Number of multiple pregnancies / number of clinical pregnancies.
implantation rate 30 months the number of gestational sacs detected with sonography at 6 weeks of pregnancy/the number of embryos transferred
Trial Locations
- Locations (11)
Guangxi Maternal and Child Health Hospital
🇨🇳Nanning, Guangxi, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Center for Reproductive Medicine, Shandong Provincial Hospital Affiliated to Shandong University
🇨🇳Jinan, Shandong, China
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Dongbei, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
The Third Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The Third Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Suzhou Municipal Hospital
🇨🇳Suzhou, Suzhou, China
Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China