Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05326087

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Preimplantation Genetic Testing Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female GnRH Antagonist Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovarian Syndrome Polycystic Ovary Syndrome Progestin-primed Ovarian Stimulation Urogenital Diseases

Age range

20 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GnRh antagonist

Drug

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

Other names: Cetrorelix

MPA

Drug

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

Primary outcomes

  1. euploidy rate

    Time frame: 1 month after oocyte retrieval

    euploidy rate of blastocysts

Secondary outcomes

  1. live birth rate

    Time frame: 1 year after embryo transfer

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

  2. cumulative live birth rate

    Time frame: 1 year after embryo transfer

    cumulative live birth within 6 months of randomization

  3. ongoing pregnancy

    Time frame: 12 weeks' gestation

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

  4. number of oocytes retrieved

    Time frame: 1 day after oocyte retrieval

    number of oocytes retrieved

  5. OHSS（ovarian hyperstimulation syndrome）

    Time frame: 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).

  6. birthweight of newborns

    Time frame: 1 year after embryo transfer

    birthweight of newborns

Study contacts

Contact information is provided by the study sponsor or research team.

HE LI, MD

CONTACT

[email protected]

+8613817223099

XIAOXI SUN, PHD

CONTACT

Sponsors and collaborators

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 13, 2022
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.