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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- live birth rate of the first FET live birth rate of the first FET live birth rate
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 43 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age of women <43 years at the time of ovarian stimulation for IVF
- •Antral follicle count (AFC) on day 2-5 of the period≥5
Exclusion Criteria
- •Presence of a functional ovarian cyst with E2>100 pg/mL
- •Recipient of oocyte donation
- •Undergoing preimplantation genetic testing
- •Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation
Arms & Interventions
PPOS group
Ovarian stimulation will use the progestin-primed ovarian stimulation (PPOS) protocol.Women will receive progesterone (oral duphaston 20mg) daily from Day 3 till the day of ovulation trigger.
Intervention: Duphaston (Drug)
Antagonist group
Ovarian stimulation will use the antagonist protocol. Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
Intervention: Cetrorelix (Drug)
Outcomes
Primary Outcomes
live birth rate of the first FET live birth rate of the first FET live birth rate
Time Frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
live birth rate of the first FET
Secondary Outcomes
- implantation rate(number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks)
- positive hCG level(a blood hCG test is performed 14 days after the FET, up to 14 days)
- ectopic pregnancy rate(ectopic pregnancy during first trimester, up to 12 weeks)
- Serum FSH level(on the day of hCG trigger, an average of 2 days after randomization)
- Serum LH level(on the day of hCG trigger, an average of 2 weeks after randomization)
- oocyte retrieved number(the number of oocyte retrieved, an average of 2 weeks after randomization)
- embryo number(the number of embryo, an average of 3 weeks after randomization)
- rate of obstetric complications(obstetric complications during pregnancy or delivery in an average of 1 year)
- Serum estradiol level(on the day of hCG trigger, an average of 2 weeks after randomization)
- ongoing pregnancy rate(viable pregnancy beyond gestation 12 weeks, up to 12 weeks)
- Serum progesterone level(on the day of hCG trigger, an average of 2 weeks after randomization)
- clinical pregnancy rate(presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks)
- miscarriage rate(a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks)
- birth weight(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 in an average of 1 month)
- multiple pregnancy rate(multiple pregnancy beyond gestation 12 weeks up to 12 weeks)
- rate of fetal or congenital defects(fetal or congenital defects found during pregnancy or delivery in an average of 1 year)