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

Hanoi General Hospital (Vietnam)

Status: Enrolling

Conditions: Female Infertility; Polycystic Ovary Syndrome (PCOS)

Treatments: Drug: GnRH Antagonist Protocol; Drug: Progestin-Primed Ovarian Stimulation (PPOS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07394530

HMUIRB2402 (Other Identifier)

HGH-IVF-PCOS-PPOS-ANT-2026

05/CN-BVĐKHN (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

PPOS Protocol

Experimental group

Description:

Participants receive ovarian stimulation using the progestin-primed ovarian stimulation (PPOS) protocol for in vitro fertilization.

Treatment:

Drug: Progestin-Primed Ovarian Stimulation (PPOS)

GnRH Antagonist Protocol

Active Comparator group

Description:

Participants receive ovarian stimulation using a GnRH antagonist protocol for in vitro fertilization.

Treatment:

Drug: GnRH Antagonist Protocol