This randomized trial aims to compare the euploid rate of blastocysts between PPOS and GnRH antagonist protocols in patients undergoing PGT-A. Infertile women who have medical indication for PGT-A will be recruited for study after explanation and counseling if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups: Antagonist group: Women will receive antagonist once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. PPOS group: Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger. The primary outcome is the euploidy rate of blastocysts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger
oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger.
Shanghai JiAi Genetics & IVF Institute
Shanghai, Shanghai Municipality, China
euploidy rate
euploidy rate of blastocysts
Time frame: 1 month after oocyte retrieval
number of mature oocytes
number of MII oocytes
Time frame: 1 day after oocyte retrieval
number and grading of blastocysts
number and grading of blastocysts suitable for biopsy and freezing
Time frame: 1 week after oocyte retrieval
positive serum hCG
serum β-hCG ≥10 mIU/mL of the first FET
Time frame: 2 weeks after FET
clinical pregnancy
presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET
Time frame: 6 weeks' gestation
implantation rate
the number of gestational sacs per blastocyst transferred of the first FET
Time frame: 6 weeks' gestation
biochemical pregnancy
positive serum hCG not followed by clinical pregnancy of the first FET
Time frame: 6 weeks' gestation
ongoing pregnancy
a viable pregnancy beyond 12 weeks' gestation of the first FET
Time frame: 12 weeks' gestation
live birth rate
deliveries ≥22 weeks gestation with heartbeat and breath of the first FET
Time frame: 1 year after FET
multiple pregnancy
more than one intrauterine sacs on scanning
Time frame: multiple pregnancy beyond gestation 12 weeks
ectopic pregnancy
pregnancy outside the uterine cavity
Time frame: ectopic pregnancy during 12 weeks' gestation
birthweight of newborns
the birth weight of newborns
Time frame: 1 year after FET
serum baseline FSH
baseline FSH of period day 2-3
Time frame: day 2-3 of period
progesterone level on the trigger day
progesterone level on the trigger day
Time frame: 2 days before oocyte retrieval
estradiol level on the trigger day
estradiol level on the trigger day
Time frame: 2 days before oocyte retrieval
miscarriage
clinically recognised pregnancy loss before 22 weeks of pregnancy.
Time frame: 22 weeks of pregnancy
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