About this trial
This randomized trial aims to compare the euploid rate of blastocysts between PPOS (progestin-primed ovarian stimulation) and GnRH (gonadotrophin releasing hormone) antagonist protocols in patients with PCOS (polycystic ovary syndrome) undergoing PGT-A (preimplantation genetic testing for aneuploidy). Infertile women with PCOS 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 MPA (medroxyprogesterone acetate)10mg qd from Day 3 till the day of ovulation trigger.
The primary outcome is the euploidy rate of blastocysts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women age between 20 and 37 years.
Women diagnosed with PCOS according to the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with the presence of ≥12 antral follicles (≤9 mm) and/or ovarian volume >10 mL on transvaginal ultrasonographic scanning, and/or clinical/ biochemical hyperandrogenism. Other causes of hyperandrogenism and ovulation dysfunction-including tumours, congenital adrenal hyperplasia, hyperprolactinaemia and thyroid dysfunction-were excluded
Disqualifiers
Presence of a functional ovarian cyst with E2>100 pg/mL
Endometriosis grade 3 or higher
Repeated implantation failure (>=4 embryos replaced or >=2 blastocysts replaced without success)
Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)
Trial design
Parallel
Treatments tested in this trial
GnRH antagonist
DrugGnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
MPA
Drugoral MPA 10mg qd from Day 3 of ovarian stimulation till the day of ovulation trigger.
Treatment groups
Trial outcomes
Primary outcomes
euploidy rate
euploidy rate of blastocysts
Secondary outcomes
live birth rate
deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer
cumulative live birth rate
cumulative live birth within 6 months of randomization
ongoing pregnancy
a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer
number of oocytes retrieved
number of oocytes retrieved
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: