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

NCT07171970 | Recruiting DMC

• 1 other identifier: 10/25/DD-BVMD
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome (PCOS); In Vitro Maturation of Oocytes; Fresh Embryo Transfer

Keywords

in vitro maturation; The SAIGON protocol; fresh embryo transfer; GnRH-Antagonist; frozen embryo transfer

Outcome Measures

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.

  At 24 weeks of gestation

Secondary Outcomes (28)

• Cumulative ongoing pregnancy

  After 12 months of follow-up after randomisation

• Time to ongoing pregnancy

  Up to 10 weeks after embryo placement

• Positive pregnancy test rate

  10-14 days after embryo transfer

• Clinical pregnancy rate

  6 weeks after embryo transfer

• Ongoing pregnancy rate

  12 weeks after embryo transfer

Study Arms (2)

IVM-Fresh (No gonadotropin + Fresh embryo transfer)

EXPERIMENTAL

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.

Procedure: IVM-Fresh (No gonadotropin + Fresh embryo transfer)

IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)

ACTIVE COMPARATOR

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.

Procedure: IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)

Interventions

IVM-Fresh (No gonadotropin + Fresh embryo transfer) PROCEDURE

Patients 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.

IVM-Fresh (No gonadotropin + Fresh embryo transfer)

IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer) PROCEDURE

Patients 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.

IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)

Eligibility Criteria

• Age: 18 Years - 42 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

IVFMD - My Duc Hospital

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Lan N Vuong, MD, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vu NA Ho, MD, PhD

CONTACT

+84935843336; bsvu.hna@myduchospital.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 15, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)