NCT07394530

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Jun 2028

Study Start

First participant enrolled

January 20, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

January 30, 2026

Last Update Submit

February 9, 2026

Conditions

Female InfertilityPolycystic Ovary Syndrome (PCOS)

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate at 12 weeks

    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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

PPOS Protocol

EXPERIMENTAL

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

Drug: Progestin-Primed Ovarian Stimulation (PPOS)

GnRH Antagonist Protocol

ACTIVE COMPARATOR

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

Drug: GnRH Antagonist Protocol

Interventions

GnRH Antagonist ProtocolDRUG

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

GnRH Antagonist Protocol
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.

PPOS Protocol

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale participants with polycystic ovary syndrome (PCOS) who are indicated for IVF treatment are eligible for this study
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanoi General Hospital

Hanoi, Hanoi, 10000, Vietnam

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility, Female

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesInfertility

Study Officials

  • Phuong Duy Nguyen, MD, MS

    Hanoi General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phuong Duy Nguyen, MD, MS

CONTACT

+84 986656835nguyenduyphuongncs44@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 6, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

VN(1)