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NCT Number: NCT07394530

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

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.

Recruiting

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Infertility, Female Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hanoi General Hospital

Hanoi, 10000, Vietnam

Location status: Recruiting

Location contact

Phuong Duy Nguyen, MD, MS

CONTACT

[email protected]

+84 986656835

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Progestin-Primed Ovarian Stimulation (PPOS)

Drug

Ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol, including gonadotropins combined with oral progestin for pituitary suppression during in vitro fertilization treatment.

GnRH Antagonist Protocol

Drug

Ovarian stimulation using a gonadotropin-releasing hormone (GnRH) antagonist protocol for pituitary suppression during in vitro fertilization treatment.

Primary outcomes

  1. Ongoing pregnancy rate at 12 weeks

    Time frame: Up to 12 weeks after embryo transfer

    Ongoing pregnancy defined as a viable intrauterine pregnancy with fetal cardiac activity confirmed by ultrasound at or beyond 12 weeks of gestation.

Secondary outcomes

  1. Number of Oocytes Retrieved

    Time frame: From ovarian stimulation start to oocyte retrieval (approximately 10-14 days)

    Total number of oocytes retrieved per ovarian stimulation cycle at the time of oocyte retrieval

  2. Number of Mature (MII) Oocytes

    Time frame: At the time of oocyte retrieval (approximately 10-14 days after stimulation start)

    Number of mature oocytes at the metaphase II (MII) stage identified at the time of oocyte retrieval

  3. Live birth rate

    Time frame: Up to delivery (approximately 9-12 months after embryo transfer)

    Live birth rate of live-born infants at ≥24 weeks of gestation or with birth weight ≥500 g and signs of life after birth.

  4. Clinical pregnancy rate

    Time frame: 6-7 weeks after embryo transfer

    Clinical pregnancy defined as the presence of a gestational sac with fetal cardiac activity confirmed by ultrasound

  5. Fertilization Rate

    Time frame: 16-18 hours after oocyte insemination

    Fertilization rate, defined as the percentage of fertilized oocytes

  6. Number of Usable Embryos

    Time frame: From fertilization to embryo assessment (approximately Day 3 to Day 5 after oocyte retrieval).

Study contacts

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

Phuong Duy Nguyen, MD, MS

CONTACT

[email protected]

+84 986656835

Sponsors and collaborators

Lead sponsor

Hanoi General Hospital (Vietnam)

Other

Registry information

Official study title

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

Acronym: PPOS-PCOS-IVF

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Feb 11, 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.

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