- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07409493
IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols
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
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thanh Huy Dao, MD
- Phone Number: +84 971597096
- Email: huythanhdao.hmu@gmail.com
Study Locations
-
-
-
Hanoi, Vietnam, 100000
- Recruiting
- Hanoi Obstetrics and Gynecology Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMUIRB2275
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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