IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols

February 12, 2026 updated by: Hanoi Medical University

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

Study Overview

Study Type

Interventional

Enrollment (Estimated)

148

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

      • Hanoi, Vietnam, 100000
        • Recruiting
        • Hanoi Obstetrics and Gynecology Hospital

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

Exclusion Criteria:

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

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
FSH + Dydrogesterone 20mg/day from day 2 - 3 of the menstrual cycle. Optional LH supplementation. Freeze-all with time-lapse monitoring.
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.
Active Comparator: Antagonist protocol
FSH + Orgalutran 0.25 mg/day (starting when follicle ≥12 mm). Optional LH supplementation. Freeze-all with time-lapse monitoring.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastocyst formation rate
Time Frame: Day 5 to Day 6 after oocyte retrieval
Number of high-quality blastocysts (grade ≥ 3BB) obtained per cycle
Day 5 to Day 6 after oocyte retrieval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embryo morphokinetic development
Time Frame: Day 2 to day 5 after oocyte retrieval
Compare the embryomorphokinetic milestones evaluated using the time-lapse evaluation system (EmbryoScope+ Vitrolife).
Day 2 to day 5 after oocyte retrieval

Collaborators and Investigators

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

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 21, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMUIRB2275

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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