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Recruiting NCT07394530

Comparison of IVF Outcomes Between PPOS and Antagonist Protocols in Women With PCOS

No phase Interventional Polycystic Ovary Syndrome (PCOS) Female Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Progestin-Primed Ovarian Stimulation (PPOS), GnRH Antagonist Protocol.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome (PCOS), Female Infertility. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Comparative Study of In Vitro Fertilization Outcomes Between PPOS and Antagonist Protocols in Women With Polycystic Ovary Syndrome

Overview

This study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol.

Interventions

  • Drug Progestin-Primed Ovarian Stimulation (PPOS)
    Ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol, including gonadotropins combined with oral progestin for pituitary suppression during in vitro fertilization treatment.
  • Drug GnRH Antagonist Protocol
    Ovarian stimulation using a gonadotropin-releasing hormone (GnRH) antagonist protocol for pituitary suppression during in vitro fertilization treatment.

Primary outcome measures

  • Ongoing pregnancy rate at 12 weeks [Time frame: Up to 12 weeks after embryo transfer]
Secondary outcome measures (6)
  • Number of Oocytes Retrieved [Time frame: From ovarian stimulation start to oocyte retrieval (approximately 10-14 days)]
  • Number of Mature (MII) Oocytes [Time frame: At the time of oocyte retrieval (approximately 10-14 days after stimulation start)]
  • Live birth rate [Time frame: Up to delivery (approximately 9-12 months after embryo transfer)]
  • Clinical pregnancy rate [Time frame: 6-7 weeks after embryo transfer]
  • Fertilization Rate [Time frame: 16-18 hours after oocyte insemination]
  • Number of Usable Embryos [Time frame: From fertilization to embryo assessment (approximately Day 3 to Day 5 after oocyte retrieval).]

Eligibility criteria

Inclusion criteria

  • Women aged 18-40 years
  • Diagnosed with polycystic ovary syndrome (PCOS) according to the modified Rotterdam criteria (2004) (≥2 of 3: oligo/anovulation, hyperandrogenism, or polycystic ovarian morphology on ultrasound)
  • Indicated for in vitro fertilization (IVF) due to PCOS alone or PCOS with other infertility factors (e.g., tubal factor, previous failed IUI)
  • Eligible for controlled ovarian stimulation for IVF
  • Husband/partner with normal sperm parameters or mild to moderate oligoasthenoteratozoospermia (OAT)
  • Willing and able to provide written informed consent and comply with study procedures.

Exclusion criteria

  • Uterine abnormalities that may impair implantation or pregnancy outcomes, including congenital uterine malformations, large fibroids distorting the uterine cavity, adenomyosis, or severe intrauterine pathology.
  • History of major ovarian or uterine surgery affecting ovarian reserve or uterine structure (e.g., ovarian cystectomy, endometriosis surgery, myomectomy, unilateral oophorectomy)
  • History of recurrent pregnancy loss (≥3 spontaneous miscarriages)
  • Known chromosomal abnormalities in either partner
  • Inability to adhere to study protocol or follow-up procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Vietnam · 1 center
  • Hanoi General Hospital — Hanoi

Identifiers

NCT: NCT07394530 · HGH-IVF-PCOS-PPOS-ANT-2026 · HMUIRB2402 · 05/CN-BVĐKHN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗