Clinical trial NCT05326087: Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A
Official title: A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the PPOS (Progestin-primed Ovarian Stimulation) Protocol and the Gonadotropin-releasing Hormone (GnRH) Antagonist Protocol in Women With PCOS (Polycystic Ovary Syndrome) Undergoing PGT-A (Preimplantation Genetic Testing for Aneuploidy)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Preimplantation Genetic Testing
Progestin-primed Ovarian Stimulation
Polycystic Ovarian Syndrome
GnRH Antagonist
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 204
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: euploidy rate
timeFrame: 1 month after oocyte retrieval
Secondary outcomes:
measure: live birth rate
timeFrame: 1 year after embryo transfer
measure: cumulative live birth rate
timeFrame: 1 year after embryo transfer
measure: ongoing pregnancy
timeFrame: 12 weeks' gestation
measure: number of oocytes retrieved
timeFrame: 1 day after oocyte retrieval
measure: OHSS（ovarian hyperstimulation syndrome）
timeFrame: 1 month after ovarian stimulation
measure: birthweight of newborns
timeFrame: 1 year after embryo transfer
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai JiAi Genetics & IVF Institute, China
name: XIAOXI SUN, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.
citation: Lee E, Illingworth P, Wilton L, Chambers GM. The clinical effectiveness of preimplantation genetic diagnosis for aneuploidy in all 24 chromosomes (PGD-A): systematic review. Hum Reprod. 2015 Feb;30(2):473-83. doi: 10.1093/humrep/deu303. Epub 2014 Nov 28.
citation: Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047.
citation: Kuang Y, Chen Q, Fu Y, Wang Y, Hong Q, Lyu Q, Ai A, Shoham Z. Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril. 2015 Jul;104(1):62-70.e3. doi: 10.1016/j.fertnstert.2015.03.022. Epub 2015 May 5.
citation: Ehrmann DA, Liljenquist DR, Kasza K, Azziz R, Legro RS, Ghazzi MN; PCOS/Troglitazone Study Group. Prevalence and predictors of the metabolic syndrome in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Jan;91(1):48-53. doi: 10.1210/jc.2005-1329. Epub 2005 Oct 25.