The Effectiveness and Safety of In Vitro Maturation With Fresh Embryo Transfer (The SAIGON Protocol) Versus In Vitro Fertilization With Frozen Embryo Transfer in Women With Polycystic Ovary Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 42
Healthy Volunteers: f
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• Women aged 18 - 42 years old.

• Diagnosed with PCOS, followed Rotterdam 2003 criteria (Group TREP consensus workshop, 2004)

• Had fewer than three previous failed frozen embryo transfer (FET) cycles

• Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts.

• Agreeing to participate in the study

Locations
Other Locations
Viet Nam
IVFMD - My Duc Hospital
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Vu NA Ho, MD, PhD
bsvu.hna@myduchospital.vn
+84935843336
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2028-01-15
Participants
Target number of participants: 600
Treatments
Experimental: IVM-Fresh (No gonadotropin + Fresh embryo transfer)
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.
Active_comparator: IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)
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.
Sponsors
Leads: Mỹ Đức Hospital

This content was sourced from clinicaltrials.gov