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Assisted Reproductive Technologies (ART) aim to increase success rates while minimizing patient risks. For women with high AFC or PCOS, conventional IVF carries a high risk of OHSS (Ho et al., 2019). A modern IVF strategy to prevent this uses a GnRH agonist trigger, requiring a "freeze-all" and subsequent FET (Wong et al., 2017). This reduces OHSS risk but can increase time to pregnancy (Vuong et al., 2021) and treatment burden.
IVM is a patient-friendly alternative that eliminates OHSS risk by avoiding high-dose gonadotropins. A 2020 trial by Vuong et al. compared CAPA-IVM-FET to conventional IVF-FET in women with high AFC. IVM yielded a comparable live birth rate (35.2%) versus IVF (43.2%), with a 0% OHSS rate in IVM compared to 0.7% in IVF (Vuong et al., 2020).
The optimal transfer method (fresh or frozen) in IVM cycles is debated. A 2021 pilot RCT by Vuong et al. found a freeze-only strategy after CAPA-IVM led to a significantly higher live birth rate (60%) than a fresh transfer (20%) (Vuong et al., 2021), but increased time to pregnancy (194 vs. 150 days) (Vuong et al., 2021). A refined CAPA-IVM protocol, which uses no gonadotropins, allowed for fresh embryo transfer in the same cycle, resulting in a numerically higher ongoing pregnancy rate (43.3% vs. 33.3%) than FET (Vuong et al., 2025).
This raises an important question: how does a simplified IVM strategy with fresh transfer compare to the established "safety-net" IVF strategy with FET? These two approaches represent opposing clinical philosophies. No large-scale study has yet compared them in women with PCOS. Therefore, this study is designed to compare the SAIGON protocol (gonadotropin-free CAPA-IVM with fresh ET) against a standard GnRH-antagonist IVF protocol with agonist trigger and subsequent FET.
Screening for eligibility and randomization: Women who are potentially eligible are provided with information about the trial. Screening is done on the day of the first visit, and patients are given informed consent form to sign before enrollment. Participants are then randomly assigned (1:1) to either the CAPA-IVM or IVF-FET group.
After randomisation 2.1. IVM-FRESH (The SAIGON Protocol):
2.2. IVF-FET (Frozen Transfer Protocol):
Pregnancy and outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVM-Fresh (No gonadotropin + Fresh embryo transfer) | Experimental | Endometrial preparation will be conducted using an artificial cycle protocol initiated on day 2-4 of the menstrual cycle (either spontaneous or induced). CAPA-IVM treatment will subsequently be performed, followed by oocyte fertilization and fresh embryo transfer. |
|
| IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer) | Active Comparator | Ovarian stimulation will be performed using a GnRH-antagonist protocol starting on any day of the menstrual cycle. Embryos obtained from ICSI will be cryopreserved for later transfer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVM-Fresh (No gonadotropin + Fresh embryo transfer) | Procedure | Patients randomized to this arm will receive estradiol valerate 8 mg/day. IVM will be performed after ≥10 days of estrogen and ET ≥8 mm. From the day of ICSI, they will continue estradiol and start vaginal progesterone 800 mg/day + dydrogesterone (20mg/day). A fresh embryo transfer will subsequently be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rates after the one embryo transfer | Live birth was defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Live births refer to the individual newborn; for example, a twin delivery represents two live births. | At 24 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative ongoing pregnancy | Cumulative ongoing pregnancy defined as the occurrence of at least one ongoing pregnancy within 12 months of follow-up after randomisation. An ongoing pregnancy is counted as 1 for each participant who achieves at least one such pregnancy within this time frame, regardless of the number of embryo transfers or pregnancies achieved. Participants who do not return for embryo transfer within the 12-month period are considered censored |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vu NA Ho, MD, PhD | Contact | +84935843336 | bsvu.hna@myduchospital.vn |
| Name | Affiliation | Role |
|---|---|---|
| Lan N Vuong, MD, PhD | University of Medicine and Pharmacy at Ho Chi Minh City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVFMD - My Duc Hospital | Recruiting | Ho Chi Minh City | Vietnam |
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Parallel Assignment
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| IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer) | Procedure | Patients randomized into this group will receive FSH at a dose of 150 IU/day. Oocyte retrieval will be performed once the criteria for triggering are fulfilled, followed by embryo cryopreservation and frozen embryo transfer in the subsequent cycle. Endometrial preparation for frozen embryo transfer will be conducted using an exogenous steroids regimen. Patients will receive estradiol 8 mg/day starting from cycle days 2-3 for 10 days. When the endometrial thickness reaches ≥8 mm, luteal phase support will be initiated with vaginal progesterone 800 mg/day plus dydrogesterone 20 mg/day. |
|
| After 12 months of follow-up after randomisation |
| Time to ongoing pregnancy | Time to ongoing pregnancy defined as the interval between randomization and the achievement of an ongoing pregnancy. | Up to 10 weeks after embryo placement |
| Positive pregnancy test rate | Positive pregnancy test rate defined as serum human chorionic gonadotropin level ≥ 25 mIU/mL. | 10-14 days after embryo transfer |
| Clinical pregnancy rate | A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. In addition to intra-uterine pregnancy, it includes a clinically documented ectopic pregnancy. | 6 weeks after embryo transfer |
| Ongoing pregnancy rate | A pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat at 12 weeks gestation or beyond | 12 weeks after embryo transfer |
| Implantation rate | The number of gestational sacs observed divided by the number of embryos transferred (usually expressed as a percentage) | 3 weeks after embryo transfer |
| Ectopic pregnancy rate | A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology. | 2 - 4 weeks after embryo transfer |
| Miscarriage rate | Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age, in which the embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus. | 2-22 weeks after embryo transfer |
| Multiple gestations rate | A pregnancy with more than one embryo or fetus | 5 weeks after embryo transfer |
| Multiple birth rate | The complete expulsion or extraction from a woman of more than one fetus, after 22 completed weeks of gestational age, irrespective of whether it is a live birth or stillbirth. Births refer to the individual newborn; for example, a twin delivery represents two births. | At 22 weeks' gestation |
| Mode of delivery | Vaginal delivery, Assisted vaginal delivery, C-section | At delivery |
| Birth weight | Weight of the newborn measured right after delivery | At delivery |
| Gestational age at birth | Calculated by gestational age of all live births | At delivery |
| Ovarian hyperstimulation syndrome | Ovarian hyperstimulation syndrome (OHSS) is a potentially lethal iatrogenic complication of the early luteal phase or/and early pregnancy after ovulation induction or ovarian stimulation. OHSS was evaluated if symptoms were reported by the patient. | Up to 1 week after the oocyte retrieval in the IVF arm |
| IVM oocyte retrieval cancellation | Record the reason for canceling in IVM arm | After 21 day of endometrial preparation |
| Embryo transfer cancellation | Record the reason for canceling. | After 21 days of endometrial preparation |
| Preterm birth | Defined as delivery at <28, <32, <37 completed weeks. A birth that takes place after 22 weeks and before 37 completed weeks of gestational age. | At delivery |
| Gestational diabetes mellitus | A 75-g OGTT, with plasma glucose measurement when the patient is fasting and at 1 and 2 h, at 24-28 weeks of gestation in women not previously diagnosed with diabetes. | At 24-28 weeks of gestation |
| Hypertensive disorders of pregnancy | Pregnancy-induced hypertension, pre-eclampsia (early and late), eclampsia, and HELLP syndrome | After 20 weeks of gestation |
| Stillbirth | The death of a fetus before the complete expulsion or extraction from its mother after 28 completed weeks of gestational age. The death is determined by the fact that, after such separation, the fetus does not breathe or show any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles. It includes deaths occurring during labor. | At delivery after 28 weeks of gestation |
| Very low birth weight | Birth weight less than 1.500 g. | At delivery |
| Low birth weight | Birth weight less than 2.500 g | At delivery |
| High birth weight | Implies growth beyond an absolute birth weight of 4.000 g, regardless of the gestational age | At delivery |
| Very high birth weight | Birth weight over 4.500 g. | At delivery |
| Major congenital abnormalities | Structural, functional, and genetic anomalies that occur during pregnancy, and are identified antenatally, at birth, or later in life, and require surgical repair of a defect, or are visually evident, or life-threatening, or cause death. Any congenital anomaly will be included as follows definition of congenital abnormalities in Surveillance of Congenital Anomalies by Division of Birth Defects and Developmental Disabilities, NCBDDD, Centers for Disease Control and Prevention (2020). | During pregnancy and 12 months after delivery |
| Postpartum hemorrhage | Defined as a blood loss of ≥ 1000 mL, or blood loss accompanied by signs or symptoms of hypovolemia, within 24 hours after birth (including intrapartum blood loss), regardless of the mode of delivery. | Up to one month after the delivery |
| NICU admission | The admission of the newborn to the NICU | Up to one month after the delivery |
| Neonatal mortality | Death of a live-born baby within 28 days of birth. This can be divided into early neonatal mortality, if death occurs in the first seven days after birth, and late neonatal if death occurs between 8 and 28 days after delivery. | Up to one month after the delivery |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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