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| Name | Class |
|---|---|
| Hanoi Obstetrics and Gynecology Hospital | OTHER |
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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:
Study Design:
Researchers will randomly assign 148 women undergoing IVF to two groups:
Participants will:
Study Location:
Department of Assisted Reproduction and Andrology, Hanoi Obstetrics and Gynecology Hospital
Study Duration: January 2026 - June 2028
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPOS protocol | Experimental | FSH + Dydrogesterone 20mg/day from day 2 - 3 of the menstrual cycle. Optional LH supplementation. Freeze-all with time-lapse monitoring. |
|
| Antagonist protocol | Active Comparator | FSH + Orgalutran 0.25 mg/day (starting when follicle ≥12 mm). Optional LH supplementation. Freeze-all with time-lapse monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progestin-Primed Ovarian Stimulation | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blastocyst formation rate | Number of high-quality blastocysts (grade ≥ 3BB) obtained per cycle | Day 5 to Day 6 after oocyte retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| Embryo morphokinetic development | Compare the embryomorphokinetic milestones evaluated using the time-lapse evaluation system (EmbryoScope+ Vitrolife). | Day 2 to day 5 after oocyte retrieval |
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Inclusion Criteria:
Exclusion Criteria:
female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thanh Huy Dao, MD | Contact | +84 971597096 | huythanhdao.hmu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi Obstetrics and Gynecology Hospital | Recruiting | Hanoi | 100000 | Vietnam |
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| Antagonist protocol for IVF | Drug | 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. |
|
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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