DRUG
GnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
Status
Not yet recruiting
Phase
Phase 3
Enrollment
204
Locations
0
Results
Not posted
Publications
5
Study summary
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.
Interventions
DRUG
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
DRUG
oral MPA 10mg qd from Day 3 of ovarian stimulation till the day of ovulation trigger.
Timeline
First posted
Apr 13, 2022
Study start
Jun 1, 2026
Primary completion
Dec 1, 2027
Study completion
Dec 1, 2028
Results posted
Not reported
Registry updated
Feb 2, 2026
Outcomes
euploidy rate
Time frame · 1 month after oocyte retrieval
euploidy rate of blastocysts
live birth rate
Time frame · 1 year after embryo transfer
deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer
cumulative live birth rate
Time frame · 1 year after embryo transfer
cumulative live birth within 6 months of randomization
ongoing pregnancy
Time frame · 12 weeks' gestation
a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer
number of oocytes retrieved
Time frame · 1 day after oocyte retrieval
number of oocytes retrieved
OHSS(ovarian hyperstimulation syndrome)
Time frame · 1 month after ovarian stimulation
Moderate or severe ovarian hyperstimulation syndrome.Ovarian hyperstimulation syndrome (OHSS) is diagnosed and classified according to the Royal College of Obstetricians and Gynaecologists guideline. Green-top guideline No.5. Ovarian hyperstimulation syndrome. https://www.rcog.org.uk/en/guidelines-research-services/guidelines/gtg5/ (accessed 26 Feb 2016).
birthweight of newborns
Time frame · 1 year after embryo transfer
birthweight of newborns
Eligibility
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease; * Recipient of oocyte donation * Presence of hydrosalpinx which is not surgically treated
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
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