Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A

Phase 3

Not yet recruiting

• Conditions: Preimplantation Genetic Testing; Progestin-primed Ovarian Stimulation; Polycystic Ovarian Syndrome; GnRH Antagonist
• Interventions: Drug: GnRH antagonist; Drug: MPA

• Registration Number: NCT05326087
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-09
• Study First Posted: 2022-04-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31
• Study Start: 2025-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antagonist group	GnRH antagonist	Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
PPOS group	MPA	Women will receive oral MPA 10mg qd from Day 3 till the day of ovulation trigger.

Primary Outcome Measures

Name	Time	Method
euploidy rate	1 month after oocyte retrieval	euploidy rate of blastocysts

Secondary Outcome Measures

Name	Time	Method
birthweight of newborns	1 year after embryo transfer	birthweight of newborns
ongoing pregnancy	12 weeks' gestation	a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer
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).
cumulative live birth rate	1 year after embryo transfer	cumulative live birth within 6 months of randomization
live birth rate	1 year after embryo transfer	deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer
number of oocytes retrieved	1 day after oocyte retrieval	number of oocytes retrieved