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

February 9, 2026 updated by: Nguyen Duy Phuong, Hanoi General Hospital (Vietnam)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PPOS Protocol
Participants receive ovarian stimulation using the progestin-primed ovarian stimulation (PPOS) protocol for in vitro fertilization.
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.
Active Comparator: GnRH Antagonist Protocol
Participants receive ovarian stimulation using a GnRH antagonist protocol for in vitro fertilization.
Drug: GnRH Antagonist Protocol
Ovarian stimulation using a gonadotropin-releasing hormone (GnRH) antagonist protocol for pituitary suppression during in vitro fertilization treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to delivery (approximately 9-12 months after embryo transfer)
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
6-7 weeks after embryo transfer
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
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)
Number of mature oocytes at the metaphase II (MII) stage identified at the time of oocyte retrieval
At the time of oocyte retrieval (approximately 10-14 days after stimulation start)
Fertilization Rate
Time Frame: 16-18 hours after oocyte insemination
Fertilization rate, defined as the percentage of fertilized oocytes
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).
From fertilization to embryo assessment (approximately Day 3 to Day 5 after oocyte retrieval).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanoi General Hospital (Vietnam)

Investigators

  • Principal Investigator: Phuong Duy Nguyen, MD, MS, Hanoi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGH-IVF-PCOS-PPOS-ANT-2026
  • HMUIRB2402 (Other Identifier: Hanoi Medical University Institutional Review Board)
  • 05/CN-BVĐKHN (Other Identifier: Ethics Committee in Biomedical Research, Hanoi Department of Health)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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