Embryo Morphokinetics, Infertility (IVF Patients), Progestins Primed Ovarian Stimulation
Conditions
Keywords
IVF, PPOS, Embryo morphokinetics
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
Interventions
DRUGProgestin-Primed Ovarian Stimulation
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.
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.
Sponsors
Hanoi Medical University
Hanoi Obstetrics and Gynecology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blastocyst formation rate | Day 5 to Day 6 after oocyte retrieval | Number of high-quality blastocysts (grade ≥ 3BB) obtained per cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Embryo morphokinetic development | Day 2 to day 5 after oocyte retrieval | Compare the embryomorphokinetic milestones evaluated using the time-lapse evaluation system (EmbryoScope+ Vitrolife). |
Countries
Vietnam
Contacts
CONTACTThanh Huy Dao, MD
Outcome results
None listed