IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorHanoi Medical University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 20-45 years
Indicated for in vitro fertilization (IVF) treatment
Planned freeze-all embryo strategy
Voluntary participation in research.
Disqualifiers
Systemic diseases
Use of hormonal medications within 3 months prior to enrollment
Oocyte donation cycles
Unwilling or unable to participate in research
Trial design
Design model
Parallel
Treatments tested in this trial
Progestin-Primed Ovarian Stimulation
DrugOvarian 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.
Antagonist protocol for IVF
DrugOvarian 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.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: PPOS protocolExperimental treatment 1 intervention
Group B: Antagonist protocolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Blastocyst formation rate
Number of high-quality blastocysts (grade ≥ 3BB) obtained per cycle
Time frame
Day 5 to Day 6 after oocyte retrievalSecondary outcomes
1
Embryo morphokinetic development
Compare the embryomorphokinetic milestones evaluated using the time-lapse evaluation system (EmbryoScope+ Vitrolife).
Time frame
Day 2 to day 5 after oocyte retrievalSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hanoi Medical University
Lead sponsor
Hanoi Obstetrics and Gynecology Hospital
Collaborator
Source ClinicalTrials.gov