Euploid Rate, GnRH Antagonist, Preimplantation Genetic Testing, Progestin-primed Ovarian Stimulation
Conditions
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.
Interventions
DRUGGnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger
DRUGoral Duphaston
oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger.
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 43 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| euploidy rate | 1 month after oocyte retrieval | euploidy rate of blastocysts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| clinical pregnancy | 6 weeks' gestation | presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET |
| implantation rate | 6 weeks' gestation | the number of gestational sacs per blastocyst transferred of the first FET |
| biochemical pregnancy | 6 weeks' gestation | positive serum hCG not followed by clinical pregnancy 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 of mature oocytes | 1 day after oocyte retrieval | number of MII oocytes |
| ectopic pregnancy | ectopic pregnancy during 12 weeks' gestation | pregnancy outside the uterine cavity |
| birthweight of newborns | 1 year after FET | the birth weight of newborns |
| serum baseline FSH | day 2-3 of period | baseline FSH of period day 2-3 |
| progesterone level on the trigger day | 2 days before oocyte retrieval | progesterone level on the trigger day |
| estradiol level on the trigger day | 2 days before oocyte retrieval | estradiol level on the trigger day |
| miscarriage | 22 weeks of pregnancy | clinically recognised pregnancy loss before 22 weeks of pregnancy. |
| multiple pregnancy | multiple pregnancy beyond gestation 12 weeks | more than one intrauterine sacs on scanning |
Countries
China
Outcome results
None listed