IVM - Fresh ET (THE SAIGON PROTOCOL) Versus IVF - FET in PCOS Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorMỹ Đức Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
IVM-Fresh (No gonadotropin + Fresh embryo transfer)
Procedure/SurgeryPatients randomized to this arm will receive estradiol valerate 8 mg/day. IVM will be performed after ≥10 days of estrogen and ET ≥8 mm. From the day of ICSI, they will continue estradiol and start vaginal progesterone 800 mg/day + dydrogesterone (20mg/day). A fresh embryo transfer will subsequently be performed.
IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)
Procedure/SurgeryPatients randomized into this group will receive FSH at a dose of 150 IU/day. Oocyte retrieval will be performed once the criteria for triggering are fulfilled, followed by embryo cryopreservation and frozen embryo transfer in the subsequent cycle. Endometrial preparation for frozen embryo transfer will be conducted using an exogenous steroids regimen. Patients will receive estradiol 8 mg/day starting from cycle days 2-3 for 10 days. When the endometrial thickness reaches ≥8 mm, luteal phase support will be initiated with vaginal progesterone 800 mg/day plus dydrogesterone 20 mg/day.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: IVM-Fresh (No gonadotropin + Fresh embryo transfer)Experimental treatment 1 intervention
Group B: IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Live birth rates after the one embryo transfer
Live birth was defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Live births refer to the individual newborn; for example, a twin delivery represents two live births.
Time frame
At 24 weeks of gestationSecondary outcomes
1
Cumulative ongoing pregnancy
Cumulative ongoing pregnancy defined as the occurrence of at least one ongoing pregnancy within 12 months of follow-up after randomisation. An ongoing pregnancy is counted as 1 for each participant who achieves at least one such pregnancy within this time frame, regardless of the number of embryo transfers or pregnancies achieved. Participants who do not return for embryo transfer within the 12-month period are considered censored
Time frame
After 12 months of follow-up after randomisation2
Time to ongoing pregnancy
Time to ongoing pregnancy defined as the interval between randomization and the achievement of an ongoing pregnancy.
Time frame
Up to 10 weeks after embryo placement3
Positive pregnancy test rate
Positive pregnancy test rate defined as serum human chorionic gonadotropin level ≥ 25 mIU/mL.
Time frame
10-14 days after embryo transfer4
Clinical pregnancy rate
A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. In addition to intra-uterine pregnancy, it includes a clinically documented ectopic pregnancy.
Time frame
6 weeks after embryo transferSponsors and contacts
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Source ClinicalTrials.gov