PPOS versus GnRH antagonist IVF protocols for women with PCOS

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

This trial will test whether a progestin-primed ovarian stimulation (PPOS) protocol or a GnRH antagonist protocol gives better IVF outcomes for women aged 18–40 with PCOS.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Hanoi General Hospital (Vietnam) (other)
• Locations: 1 site (Hanoi, Hanoi)
• Trial ID: NCT07394530 on ClinicalTrials.gov

What this trial studies

Women meeting modified Rotterdam criteria for PCOS who are indicated for IVF will receive one of two controlled ovarian stimulation approaches: a progestin-primed ovarian stimulation (PPOS) protocol or a GnRH antagonist protocol. Key IVF outcomes such as number of oocytes retrieved, fertilization and embryo quality, pregnancy rates, and rates of complications (including ovarian hyperstimulation) will be recorded and compared between groups. Eligible participants are 18–40 years old, have PCOS, and a partner with normal or mildly-to-moderately abnormal sperm parameters; major uterine or prior ovarian surgery that impairs outcomes are exclusionary. The protocol is conducted at Hanoi General Hospital with standard IVF monitoring and follow-up visits.

Who should consider this trial

Good fit: Women aged 18–40 diagnosed with PCOS by the modified Rotterdam criteria who are planning IVF and whose partners have normal or only mildly to moderately abnormal sperm are the intended participants.

Not a fit: Women with significant uterine abnormalities, major prior ovarian or uterine surgery affecting reserve or structure, or other exclusionary conditions are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, the results could help clinicians choose the stimulation method that yields more eggs or higher pregnancy rates while reducing complications for women with PCOS.

How similar studies have performed: Previous studies comparing PPOS and antagonist protocols have generally reported similar embryo yield and pregnancy rates, with some evidence that PPOS can reduce ovarian hyperstimulation risk, though results are mixed.

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

Where this trial is running

Hanoi, Hanoi

• Hanoi General Hospital — Hanoi, Hanoi, Vietnam (RECRUITING)

Study contacts

• Principal investigator: Phuong Duy Nguyen, MD, MS — Hanoi General Hospital
• Study coordinator: Phuong Duy Nguyen, MD, MS

Conditions: Polycystic Ovary Syndrome, Female Infertility