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Clinical Trials/NCT07394530
NCT07394530RecruitingNot Applicable

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

Hanoi General Hospital (Vietnam)1 site in 1 country400 target enrollmentStarted: January 20, 2026Last updated:
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Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
Ongoing pregnancy rate at 12 weeks
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

PPOS Protocol

Experimental

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

Intervention: Progestin-Primed Ovarian Stimulation (PPOS) (Drug)

GnRH Antagonist Protocol

Active Comparator

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

Intervention: GnRH Antagonist Protocol (Drug)

Outcomes

Primary Outcomes

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

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

Investigators

Sponsor
Hanoi General Hospital (Vietnam)
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nguyen Duy Phuong

Medical Doctor

Hanoi Medical University

Study Sites (1)

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