Preimplantation Genetic Testing, Progestin-primed Ovarian Stimulation, Polycystic Ovarian Syndrome, GnRH Antagonist
Conditions
Brief 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
DRUGGnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
DRUGMPA
oral MPA 10mg qd from Day 3 of ovarian stimulation 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 37 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| euploidy rate | 1 month after oocyte retrieval | euploidy rate of blastocysts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| live birth rate | 1 year after embryo transfer | deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer |
| cumulative live birth rate | 1 year after embryo transfer | cumulative live birth within 6 months of randomization |
| ongoing pregnancy | 12 weeks' gestation | a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer |
| number of oocytes retrieved | 1 day after oocyte retrieval | number of oocytes retrieved |
| OHSS（ovarian hyperstimulation syndrome） | 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 | 1 year after embryo transfer | birthweight of newborns |
Contacts
CONTACTHE LI, MD
CONTACTXIAOXI SUN, PHD
PRINCIPAL_INVESTIGATORXIAOXI SUN, PHD
Shanghai JiAi Genetics & IVF Institute, China
Outcome results
None listed