Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Patients Undergoing PGT-A
- Conditions
- Progestin-primed Ovarian StimulationGnRH AntagonistPreimplantation Genetic TestingEuploid Rate
- Interventions
- Registration Number
- NCT04414748
- Lead Sponsor
- ShangHai Ji Ai Genetics & IVF Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 400
- Age of women <43 years at the time of ovarian stimulation for IVF
- Antral follicle count (AFC) >=5 on day 2-5 of the period
- PGT-A indicated for advanced maternal age (>=38 years), recurrent miscarriage (>=2 consecutive miscarriage) and repeated implantation failure (>=4 embryos replaced or >=2 blastocysts replaced without success), recurrent foetal aneuploidy
- Presence of a functional ovarian cyst with E2>100 pg/mL
- Recipient of oocyte donation
- Presence of hydrosalpinx or endometrial polyp which is not surgically treated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antagonist group GnRH antagonist Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. PPOS group oral Duphaston Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger.
- Primary Outcome Measures
Name Time Method euploidy rate 1 month after oocyte retrieval euploidy rate of blastocysts
- Secondary Outcome Measures
Name Time Method clinical pregnancy 6 weeks' gestation presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET
biochemical pregnancy 6 weeks' gestation positive serum hCG not followed by clinical pregnancy of the first FET
number of mature oocytes 1 day after oocyte retrieval number of MII oocytes
implantation rate 6 weeks' gestation the number of gestational sacs per blastocyst transferred of the first FET
ongoing pregnancy 12 weeks' gestation a viable pregnancy beyond 12 weeks' gestation of the first FET
live birth rate 1 year after FET deliveries ≥22 weeks gestation with heartbeat and breath of the first FET
number and grading of blastocysts 1 week after oocyte retrieval number and grading of blastocysts suitable for biopsy and freezing
positive serum hCG 2 weeks after FET serum β-hCG ≥10 mIU/mL of the first FET
serum baseline FSH day 2-3 of period baseline FSH of period day 2-3
multiple pregnancy multiple pregnancy beyond gestation 12 weeks more than one intrauterine sacs on scanning
ectopic pregnancy ectopic pregnancy during 12 weeks' gestation pregnancy outside the uterine cavity
estradiol level on the trigger day 2 days before oocyte retrieval estradiol level on the trigger day
progesterone level on the trigger day 2 days before oocyte retrieval progesterone level on the trigger day
miscarriage 22 weeks of pregnancy clinically recognised pregnancy loss before 22 weeks of pregnancy.
birthweight of newborns 1 year after FET the birth weight of newborns
Trial Locations
- Locations (1)
Shanghai JiAi Genetics & IVF Institute
🇨🇳Shanghai, Shanghai, China