Frozen Embryo Transfer, IVF
Conditions
Brief summary
This randomized trial we aim to compare the live birth rate of immediate versus delayed FET replacing a single blastocyst in the first FET of the first stimulated IVF cycle following. The hypothesis is that the live birth rate of the immediate FET is higher than the delayed FET replacing a single blastocyst in the first FET of the first stimulated IVF cycle following a freeze-all strategy. Women will undergo IVF/ICSI in the centre as clinically indicated. Standard ovarian stimulation with gonadotrophins in a Gonadotrophin releasing hormone (GnRH) antagonist protocol will be employed. Hormone replacement treatment (HRT) will be used in subsequent FET cycles. On Day 3 of the menstrual cycle, we will measure the anxiety levels using the Chinese State-Trait Anxiety Inventory and serum E2, cortisol levels will be checked on the same day. Recruited women having the first FET cycle following a freeze all strategy will be randomly assigned on the day of blastocyst(s) freezing according to a computer-generated randomization list into one of the following two groups.
Interventions
PROCEDUREImmediate FET
FET is performed in the first menstrual cycle following the stimulated IVF cycle
PROCEDUREDelayed FET
FET is performed in the second menstrual cycle following the stimulated IVF cycle
Sponsors
ShangHai Ji Ai Genetics & IVF Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 20-40 years at the time of IVF/ICSI 2. Women undergoing their first FET of the first IVF cycle following a freeze-all strategy 3. Undergoing IVF with GnRH antagonist 4. At least one frozen blastocyst
Exclusion criteria
1. Severe ovarian hyperstimulation syndrome during the first IVF/ICSI cycle 2. Preimplantation genetic testing 3. Use of donor oocytes 4. Presence of untreated hydrosalpinx or endometrial polyp on scanning during ovarian stimulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| live birth | 1 year after FET | deliveries ≥22 weeks gestation with heartbeat and breath |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| birthweight of newborns | 1 year after FET | the birth weight of newborns |
| miscarriage | 1 year after FET | a clinically recognized pregnancy loss before the 22 weeks of pregnancy |
| multiple pregnancy | multiple pregnancy beyond gestation 12 weeks | more than one intrauterine sacs on scanning |
| positive hCG | 2 weeks after FET | serum β-hCG ≥10 mIU/mL |
| clinical pregnancy | 6 weeks' gestation | presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks. |
| ongoing pregnancy | 12 weeks' gestation | a viable pregnancy beyond 12 weeks' gestation |
| ectopic pregnancy | ectopic pregnancy during 12 weeks gestation | pregnancy outside the uterine cavity |
| implantation rate | 6 weeks' gestation | the number of gestational sacs per blastocyst transferred |
Countries
China
Contacts
STUDY_DIRECTORXiaoxi Sun, Phd
Shanghai JiAi Genetics & IVF Institute
Outcome results
None listed