IVM - Fresh ET (THE SAIGON PROTOCOL) Versus IVF - FET in PCOS Women

Recruiting now · Not applicable

Conditions studied: Polycystic Ovary Syndrome (PCOS), In Vitro Maturation of Oocytes, Fresh Embryo Transfer

In brief

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.

Key facts

Study ID

NCT07171970

Run by

Mỹ Đức Hospital

People needed

600

Starts

2025-09-22

Expected to finish

2028-01-15

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Having allergy and contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease)
• Cycles with preimplantation genetic testing indication
• Oocyte donation cycles
• Having untreated uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus, large leiomyoma ≥5 cm in diameter; adenomyosis, endometrial polyp, hydrosalpinx).

Where it is running

• IVFMD - My Duc Hospital — Ho Chi Minh City, Vietnam (enrolling)

Full record on ClinicalTrials.gov

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