IVM fresh embryo transfer (Saigon protocol) versus IVF with frozen embryo transfer for women with PCOS

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

This trial tests whether in vitro maturation with a fresh embryo transfer (the Saigon protocol) helps women with PCOS get pregnant as well as conventional IVF followed by a frozen embryo transfer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 42 Years
• Sex: Female
• Sponsor: Mỹ Đức Hospital (other)
• Locations: 1 site (Ho Chi Minh City)
• Trial ID: NCT07171970 on ClinicalTrials.gov

What this trial studies

Women with PCOS and generally high antral follicle counts are randomized 1:1 to either CAPA-IVM with a fresh embryo transfer (the Saigon protocol) or conventional GnRH-antagonist ovarian stimulation with an agonist trigger and freeze-all followed by frozen embryo transfer. The IVM arm avoids high-dose gonadotropins, uses oral estradiol for endometrial preparation, retrieves immature oocytes for ICSI, and gives luteal support before a scheduled fresh transfer. The IVF arm uses rFSH (starting ~150 IU/day) with antagonist co-treatment, an agonist trigger for final oocyte maturation, ICSI of mature oocytes, and subsequent frozen embryo transfer. The trial compares clinical outcomes including pregnancy and live birth rates as well as complications such as ovarian hyperstimulation syndrome between the two approaches.

Who should consider this trial

Good fit: Ideal candidates are women aged 18–42 with PCOS by Rotterdam criteria, generally high antral follicle counts, fewer than three prior failed FET cycles, and no contraindications to hormone therapy.

Not a fit: Patients with contraindications to exogenous hormones, those needing preimplantation genetic testing, oocyte donation cycles, or with untreated significant uterine or adnexal abnormalities would be excluded or unlikely to benefit.

Why it matters

Potential benefit: If successful, the Saigon IVM approach could eliminate OHSS risk, shorten time to pregnancy by allowing fresh transfer, and maintain comparable live birth rates.

How similar studies have performed: Prior randomized trials and pilot data (e.g., Vuong et al.) have shown IVM can produce comparable live birth rates with near-zero OHSS and a pilot suggested freeze-only IVM may increase live birth in a small sample, supporting feasibility but not definitive superiority.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Ho Chi Minh City

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

Study contacts

• Principal investigator: Lan N Vuong, MD, PhD — University of Medicine and Pharmacy at Ho Chi Minh City
• Study coordinator: Vu NA Ho, MD, PhD

Conditions: Polycystic Ovary Syndrome, In Vitro Maturation of Oocytes, Fresh Embryo Transfer, in vitro maturation, The SAIGON protocol, fresh embryo transfer, GnRH-Antagonist, frozen embryo transfer