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Compares two fertility treatments in women with polycystic ovary syndrome

Compares an egg maturation method with fresh embryo transfer against standard IVF with frozen transfer.

Key facts

Who runs it
Mỹ Đức Hospital
Where
Ho Chi Minh City, VietnamSee the site
Trial code
Registry title
IVM - Fresh ET (THE SAIGON PROTOCOL) Versus IVF - FET in PCOS Women
Status
Recruiting
People taking part
600 people, planned
Started
22 Sept 2025
Expected to end
15 Jan 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • IVM-Fresh (No gonadotropin + Fresh embryo transfer)
  • IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)
Record updated
1 October 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with polycystic ovary syndrome (PCOS) who are having fertility treatment. It compares two ways of doing it: in vitro maturation with a fresh embryo transfer, and in vitro fertilization with a frozen embryo transfer.

Age
18 to 42 years
Sex
Women only
Disease stage
Diagnosed with PCOS by the Rotterdam 2003 criteria.
Earlier treatment
Fewer than three previous failed frozen embryo transfer (FET) cycles.

Main reasons for not taking part

  • Allergy or a medical reason not to take added hormones (for example breast cancer, blood clot disease)
  • Cycles that need genetic testing of the embryo before transfer
  • Egg donation cycles
  • Untreated problems of the womb or ovaries area (for example intrauterine adhesions, large leiomyoma 5 cm (2 in) or more, adenomyosis, endometrial polyp, hydrosalpinx)

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 42 years old?

Where in Vietnam

  • IVFMD - My Duc HospitalHo Chi Minh City, VietnamContact: Tuong M Ho, MDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • IVM-Fresh (No gonadotropin + Fresh embryo transfer)Treatment being tested

    Endometrial preparation will be conducted using an artificial cycle protocol initiated on day 2-4 of the menstrual cycle (either spontaneous or induced). CAPA-IVM treatment will subsequently be performed, followed by oocyte fertilization and fresh embryo transfer.

  • IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)Existing treatment, for comparison

    Ovarian stimulation will be performed using a GnRH-antagonist protocol starting on any day of the menstrual cycle. Embryos obtained from ICSI will be cryopreserved for later transfer.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Compares two fertility treatments in women with polycystic ovary syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07171970, who can take part
Record updated
1 October 2025