IVM fresh embryo transfer (Saigon protocol) versus IVF with frozen embryo transfer for women with PCOS
Official title: 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
Run by Mỹ Đức Hospital · NCT07171970 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 42 Years |
| Sex | Women only |
| Enrollment | 600 (estimated) |
| Sponsor | Mỹ Đức Hospital Academic / other |
| Locations | 1 site (Ho Chi Minh City) |
| Status | Recruiting |
| Started | September 22, 2025 |
| Main results expected | October 1, 2027 |
| Study ends | January 15, 2028 |
| Registry record updated | October 1, 2025 |
| Trial ID | NCT07171970 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: bsvu.hna@myduchospital.vn
- Phone: +84935843336
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using LC-MS/MS to profile androgens for PCOS diagnosis
This study tests whether LC-MS/MS measurement of androgen profiles can help diagnose PCOS in women compared with healthy controls.
-
Brown adipose tissue responses in PCOS with infrared thermography and inositol
This study tests whether brown fat activity, measured by infrared skin temperature and UCP-1 levels, differs among women with PCOS (normal weight or overweight/obese) and healthy controls, and whether 12 weeks of inositol changes those responses in overweight/obese PCOS participants.
-
GnRH for luteal support in IVF with a GnRH antagonist protocol
This observational study tests whether using a GnRH agonist or vaginal progesterone as luteal support helps pregnant outcomes for women undergoing IVF with a GnRH antagonist protocol and fresh embryo transfer.
-
Risk tool for blood-clotting problems in adolescents and women with PCOS
This project will try to build a risk model to spot decreased protein C or S and other clotting abnormalities in females aged 14–45 who have PCOS.
-
Polycystic Ovary Syndrome in Type 1 Diabetes
This study tests whether women with type 1 diabetes and PCOS differ from other groups in factors that drive androgen excess and what that means for health.
-
PPOS versus GnRH antagonist IVF protocols for women with PCOS
This trial will test whether a progestin-primed ovarian stimulation (PPOS) protocol or a GnRH antagonist protocol gives better IVF outcomes for women aged 18–40 with PCOS.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.