Infertility (IVF Patients)NCT07409493
IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols
A study testing Progestin-Primed Ovarian Stimulation and Antagonist protocol for IVF in people with Infertility (IVF Patients) and Embryo Morphokinetics, run by Hanoi Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility (IVF Patients), Embryo Morphokinetics, Progestins Primed Ovarian Stimulation
- What is being tested?
- Progestin-Primed Ovarian Stimulation and Antagonist protocol for IVF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteVietnam
- Study dates
- 21 Jan 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 20-45 years
- Indicated for in vitro fertilization (IVF) treatment
- Planned freeze-all embryo strategy
- Voluntary participation in research.
Who cannot join
- Systemic diseases
- Use of hormonal medications within 3 months prior to enrollment
- Oocyte donation cycles
- Unwilling or unable to participate in research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi Obstetrics and Gynecology Hospital
Hanoi, 100000
About this study
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?
Read more
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
- Being tested
- Progestin-Primed Ovarian Stimulation, Antagonist protocol for IVF
- Keywords
- IVF, PPOS, Embryo morphokinetics
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| PPOS protocol | Experimental | FSH + Dydrogesterone 20mg/day from day 2 - 3 of the menstrual cycle. Optional LH supplementation. Freeze-all with time-lapse monitoring. Receives: 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. Receives: Drug: Antagonist protocol for IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst formation rate
Number of high-quality blastocysts (grade ≥ 3BB) obtained per cycle
Measured: Day 5 to Day 6 after oocyte retrieval
Secondary outcomes (1)
Embryo morphokinetic development
Compare the embryomorphokinetic milestones evaluated using the time-lapse evaluation system (EmbryoScope+ Vitrolife).
Measured: Day 2 to day 5 after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start21 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Obstetrics and Gynecology Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409493
- Sponsor's protocol ID
- HMUIRB2275
- Status last verified
- Nov 2025
- First submitted
- 6 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols
- ClinicalTrials.gov ID
- NCT07409493
- Acronym / sponsor ID
- HMUIRB2275
- Keywords
- IVF, PPOS, Embryo morphokinetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Collaborators
- Hanoi Obstetrics and Gynecology Hospital
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPOS protocol | Experimental | Drug: Progestin-Primed Ovarian StimulationFSH + Dydrogesterone 20mg/day from day 2 - 3 of the menstrual cycle. Optional LH supplementation. Freeze-all with time-lapse monitoring. |
| Antagonist protocol | Active comparator | Drug: Antagonist protocol for IVFFSH + Orgalutran 0.25 mg/day (starting when follicle ≥12 mm). Optional LH supplementation. Freeze-all with time-lapse monitoring. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 20-45 years
- Indicated for in vitro fertilization (IVF) treatment
- Planned freeze-all embryo strategy
- Voluntary participation in research.
Key exclusion criteria (4 listed)
- Systemic diseases
- Use of hormonal medications within 3 months prior to enrollment
- Oocyte donation cycles
- Unwilling or unable to participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progestin-Primed Ovarian StimulationOvarian 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. | Drug | PPOS protocol |
| Antagonist protocol for IVFOvarian 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. | Drug | Antagonist protocol |
Primary outcome
Blastocyst formation rate
Time frame: Day 5 to Day 6 after oocyte retrieval
Number of high-quality blastocysts (grade ≥ 3BB) obtained per cycle
1 secondary outcome
Embryo morphokinetic development
Time frame: Day 2 to day 5 after oocyte retrieval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progestin-Primed Ovarian Stimulation and Antagonist protocol for IVF in people with Infertility (IVF Patients) and Embryo Morphokinetics, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thanh Huy Dao, MD (+84 971597096, huythanhdao.hmu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastocyst formation rate (time frame: Day 5 to Day 6 after oocyte retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.