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Not yet recruitingNCT05326087Updated Feb 2, 2026

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

A Phase 3 interventional study of GnRH antagonist and MPA in Preimplantation Genetic Testing, Progestin-primed Ovarian Stimulation and Polycystic Ovarian Syndrome, sponsored by ShangHai Ji Ai Genetics & IVF Institute. Not yet recruiting. Open to female participants aged 20 Years to 37 Years. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by ShangHai Ji Ai Genetics & IVF Institute · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
20 Years to 37 Years
Sex
Female
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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.

02

Conditions studied

  • Preimplantation Genetic Testing
  • Progestin-primed Ovarian Stimulation
  • Polycystic Ovarian Syndrome
  • GnRH Antagonist
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's planned enrollment of 204 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute is the lead sponsor of 24 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 37 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
204 participants (estimated)

Study arms

  • Active comparator
    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.

    Drug: GnRH antagonist

  • Experimental
    PPOS group

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

    Drug: MPA

Interventions

  • DrugGnRH antagonist

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

    Also known as: Cetrorelix

  • DrugMPA

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

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What researchers measure

Primary outcomes

  1. euploidy rate

    euploidy rate of blastocysts

    Time frame: 1 month after oocyte retrieval

Secondary outcomes

  1. live birth rate

    deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer

    Time frame: 1 year after embryo transfer

  2. cumulative live birth rate

    cumulative live birth within 6 months of randomization

    Time frame: 1 year after embryo transfer

  3. ongoing pregnancy

    a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer

    Time frame: 12 weeks' gestation

  4. number of oocytes retrieved

    number of oocytes retrieved

    Time frame: 1 day after oocyte retrieval

  5. OHSS（ovarian hyperstimulation syndrome）

    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).

    Time frame: 1 month after ovarian stimulation

  6. birthweight of newborns

    birthweight of newborns

    Time frame: 1 year after embryo transfer

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 30927417 ↗
  • 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. PubMed 25432917 ↗
  • 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. PubMed 28062551 ↗
  • 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. PubMed 25956370 ↗
  • 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. PubMed 16249284 ↗

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared.

Supporting information: Study protocol, Sap

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05326087
Lead sponsor
ShangHai Ji Ai Genetics & IVF Institute
Responsible party
Sponsor
First posted
Apr 13, 2022
Start date
Jun 1, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Feb 2, 2026

Study contacts

HE LI, MD
Contact
lihe198900@163.com
+8613817223099
XIAOXI SUN, PHD
Contact
XIAOXI SUN, PHD
principal investigator · Shanghai JiAi Genetics & IVF Institute, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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