NCT07409493

Brief Summary

The goal of this clinical trial is to compare two ovarian stimulation protocols used in in vitro fertilization (IVF): the fixed Progestin-Primed Ovarian Stimulation (PPOS) protocol and the GnRH Antagonist protocol. The study will evaluate IVF outcomes and embryo development patterns using time-lapse embryo monitoring technology. The main questions the study aims to answer are:

  • Does the fixed - PPOS protocol achieve similar numbers of mature eggs, good-quality embryos, and clinical outcomes compared to the GnRH Antagonist protocol?
  • Are there differences in embryo development patterns (morphokinetics) between the two protocols when monitored by time-lapse imaging?
  • How does embryo quality (KIDScore) compare between the two protocols? Study Design: Researchers will randomly assign 148 women undergoing IVF to two groups:
  • PPOS group (n=74): Will receive FSH injections (oral Duphaston 20mg daily) starting from day 2-3 of the menstrual cycle
  • GnRH Antagonist group (n=74): Will receive FSH injections (Orgalutran 0.25mg injections) when follicles reach ≥14mm Participants will:
  • Undergo controlled ovarian stimulation with their assigned protocol for approximately 10-12 days
  • Have regular ultrasound monitoring and blood tests to track follicle development
  • Undergo egg retrieval procedure when follicles are mature
  • Have all embryos cultured in the EmbryoScope time-lapse incubator with continuous monitoring
  • Have embryos frozen on Day 5/6 for future transfer Study Location: Department of Assisted Reproduction and Andrology, Hanoi Obstetrics and Gynecology Hospital Study Duration: January 2026 - June 2028

Trial Health

77
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
29mo 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 2026Oct 2028

Study Start

First participant enrolled

January 21, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

February 13, 2026

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

February 6, 2026

Last Update Submit

February 12, 2026

Conditions

Infertility (IVF Patients)Embryo MorphokineticsProgestins Primed Ovarian Stimulation

Keywords

IVFPPOSEmbryo morphokinetics

Outcome Measures

Primary Outcomes (1)

  • Blastocyst formation rate

    Number of high-quality blastocysts (grade ≥ 3BB) obtained per cycle

    Day 5 to Day 6 after oocyte retrieval

Secondary Outcomes (1)

  • Embryo morphokinetic development

    Day 2 to day 5 after oocyte retrieval

Study Arms (2)

PPOS protocol

EXPERIMENTAL

FSH + Dydrogesterone 20mg/day from day 2 - 3 of the menstrual cycle. Optional LH supplementation. Freeze-all with time-lapse monitoring.

Drug: Progestin-Primed Ovarian Stimulation

Antagonist protocol

ACTIVE COMPARATOR

FSH + Orgalutran 0.25 mg/day (starting when follicle ≥12 mm). Optional LH supplementation. Freeze-all with time-lapse monitoring.

Drug: Antagonist protocol for IVF

Interventions

Progestin-Primed Ovarian StimulationDRUG

Ovarian stimulation using progestin-primed ovarian stimulation (PPOS) protocol. Patients receive recombinant FSH starting from day 2-3 of menstrual cycle, concomitantly with oral Dydrogesterone 20mg daily to prevent premature LH surge. All embryos are cultured using time-lapse technology and cryopreserved for subsequent frozen embryo transfer.

PPOS protocol
Antagonist protocol for IVFDRUG

Ovarian stimulation using GnRH antagonist protocol. Patients receive recombinant FSH starting from day 2-3 of menstrual cycle. GnRH antagonist is added when leading follicle reaches 12-14mm diameter to prevent premature LH surge. All embryos are cultured using time-lapse technology and cryopreserved for subsequent frozen embryo transfer.

Antagonist protocol

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 20-45 years
  • Indicated for in vitro fertilization (IVF) treatment
  • Planned freeze-all embryo strategy
  • Voluntary participation in research.

You may not qualify if:

  • Systemic diseases
  • Use of hormonal medications within 3 months prior to enrollment
  • Oocyte donation cycles
  • Unwilling or unable to participate in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanoi Obstetrics and Gynecology Hospital

Hanoi, 100000, Vietnam

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Thanh Huy Dao, MD

CONTACT

+84 971597096huythanhdao.hmu@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
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 13, 2026

Study Start

January 21, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

February 13, 2026

Record last verified: 2025-11

Locations

VN(1)