A randomized comparison of the live birth rate between the progestin-primed ovarian stimulation protocol and the gonadotrophin releasing hormone antagonist protocol in patients undergoing in vitro fertilization Research question Does the live birth rate of the progestin-primed ovarian stimulation protocol comparable with the GnRH antagonist protocol for patients undergoing IVF? Design This is a randomized controlled trial. Research plan Population: Infertile women who have medical indication for IVF will be recruited for study if they fulfil the selection criteria. Intervention: Women will receive oral dydrogesterone 20mg daily from Day 3 till the day of ovulation trigger. Comparator: Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. Outcomes: The primary outcome is the live birth rate the first FET. Ovarian stimulation, egg retrieval, embryos frozen and frozen embryo transfer will be performed according to the standard operating procedures of the centres.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Women will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger.
Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
ShangHai JIAI Genetics&IVF Institute
Shanghai, China
live birth rate of the first FET live birth rate of the first FET live birth rate
live birth rate of the first FET
Time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
Serum estradiol level
Serum estradiol level on the day of hCG trigger
Time frame: on the day of hCG trigger, an average of 2 weeks after randomization
Serum progesterone level
Serum progesterone level on the day of hCG trigger
Time frame: on the day of hCG trigger, an average of 2 weeks after randomization
Serum LH level
Serum LH level on the day of hCG trigger
Time frame: on the day of hCG trigger, an average of 2 weeks after randomization
Serum FSH level
Serum FSH level on Day 2 of the period
Time frame: on the day of hCG trigger, an average of 2 days after randomization
oocyte retrieved number
Time frame: the number of oocyte retrieved, an average of 2 weeks after randomization
embryo number
Time frame: the number of embryo, an average of 3 weeks after randomization
positive hCG level
defined with the result of serum β-hCG ≥10 mIU/mL
Time frame: a blood hCG test is performed 14 days after the FET, up to 14 days
clinical pregnancy rate
presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
Time frame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks
ongoing pregnancy rate
presence of a fetal pole with pulsation at 12 weeks of gestation
Time frame: viable pregnancy beyond gestation 12 weeks, up to 12 weeks
implantation rate
number of gestational sacs per embryo transferred
Time frame: number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks
multiple pregnancy rate
more than one intrauterine sacs on scanning
Time frame: multiple pregnancy beyond gestation 12 weeks up to 12 weeks
miscarriage rate
defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy. The denominator is the clinical pregnancy.
Time frame: a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks
ectopic pregnancy rate
pregnancy outside the uterine cavity
Time frame: ectopic pregnancy during first trimester, up to 12 weeks
birth weight
birth weight of the baby delivered
Time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
rate of participants with adverse events
adverse events during COH
Time frame: adverse events during COH in an average of 1 month
rate of obstetric complications
obstetric complications during pregnancy or delivery. The information will be acquired by contacting all the participants through phone
Time frame: obstetric complications during pregnancy or delivery in an average of 1 year
rate of fetal or congenital defects
fetal or congenital defects found during pregnancy or delivery. The information will be acquired by contacting all the participants through phone
Time frame: fetal or congenital defects found during pregnancy or delivery in an average of 1 year
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