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

NCT ID: NCT05326087

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-01

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.

Conditions

Preimplantation Genetic Testing; Progestin-primed Ovarian Stimulation; Polycystic Ovarian Syndrome; GnRH Antagonist

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antagonist group

Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

Group Type: ACTIVE_COMPARATOR

GnRH antagonist

Intervention Type: DRUG

GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger

PPOS group

Women will receive oral MPA 10mg qd from Day 3 till the day of ovulation trigger.

Group Type: EXPERIMENTAL

MPA

Intervention Type: DRUG

oral MPA 10mg qd from Day 3 of ovarian stimulation till the day of ovulation trigger.

Interventions

GnRH antagonist

GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger

Intervention Type: DRUG

MPA

oral MPA 10mg qd from Day 3 of ovarian stimulation till the day of ovulation trigger.

Intervention Type: DRUG

Other Intervention Names

Cetrorelix

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ShangHai Ji Ai Genetics & IVF Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

XIAOXI SUN, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai JiAi Genetics & IVF Institute, China

Central Contacts

HE LI, MD

Role: CONTACT

lihe198900@163.com

+8613817223099

XIAOXI SUN, PHD

Role: CONTACT

References

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.

Reference Type: BACKGROUND

PMID: 30927417 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25432917 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28062551 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25956370 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16249284 (View on PubMed)

Other Identifiers

JIAI 2022-03

Identifier Type: -

Identifier Source: org_study_id