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

RecruitingNAAges 18 Years - 42 YearsFemaleMแปน ฤแปฉc Hospital
NCT07171970 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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-onl

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ5 cm in diameter; adenomyosis, endometrial polyp, hydrosalpinx).
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What it tests

  • IVM-Fresh (No gonadotropin + Fresh embryo transfer)
  • IVF-FET (GnRH-Antagonist - Agonist Trigger - Frozen embryo transfer)
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Where

1 site
IVFMD - My Duc Hospital
Ho Chi Minh City, Vietnam
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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