Actively Recruiting
IVM - Fresh ET (THE SAIGON PROTOCOL) Versus IVF - FET in PCOS Women
Led by Mỹ Đức Hospital · Updated on 2025-10-01
600
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IVM - Fresh ET (THE SAIGON PROTOCOL) Versus IVF - FET in PCOS Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 - 42 years old
- Diagnosed with PCOS according to Rotterdam 2003 criteria
- Had fewer than three previous failed frozen embryo transfer cycles
- Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts
- Agree to participate in the study
You will not qualify if you...
- Allergy or contraindications to exogenous hormone treatments (e.g., breast cancer, thromboembolic disease)
- Cycles requiring preimplantation genetic testing
- Oocyte donation cycles
- Untreated uterine or adnexal abnormalities (e.g., intrauterine adhesions, uterine malformations, large leiomyoma ≥5 cm, adenomyosis, endometrial polyp, hydrosalpinx)
AI-Screening
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Trial Site Locations
Total: 1 location
1
IVFMD - My Duc Hospital
Ho Chi Minh City, Vietnam
Actively Recruiting
Research Team
V
Vu NA Ho, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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