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225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women

RecruitingNAAges 18 Years - 34 YearsFemaleVietnam Military Medical University
NCT07772375 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized controlled trial will compare two starting doses of follicle-stimulating hormone (FSH), 225 IU and 300 IU, during progestin-primed ovarian stimulation (PPOS) in women undergoing in vitro fertilization (IVF) who have a good reproductive prognosis. Participants will be randomly assigned to receive either 225 IU or 300 IU of FSH at the start of ovarian stimulation. The study will evaluate whether the starting FSH dose affects oocyte and embryo outcomes, with blastocyst formation as the primary outcome. Other outcomes will include oocyte morphology, fertilization, embryo development, and embryo quality. The findings may help determine an appropriate starting FSH dose for women with a good prognosis undergoing IVF using the PPOS protocol.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female patient or oocyte donor aged \<35 years. * Body mass index (BMI) between 18 and 25 kg/m². * Normal ovarian reserve, defined by: * Antral follicle count (AFC) ≥8 on ultrasound; and * AMH level between 1.5 and 4.5 ng/mL. * First IVF treatment cycle. * Controlled ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol with recombinant FSH and dydrogesterone. * Indication for in vitro fertilization using intracytoplasmic sperm injection (ICSI). * Indication for extended embryo culture to the blastocyst stage. * Willingness to participate in the study and provision of written informed consent. Exclusion Criteria: * Polycystic ovary syndrome (PCOS) diagnosed according to the Rotterdam criteria, currently referred to as polyendocrine metabolic ovarian syndrome (PMOS). * Structural abnormalities of the ovaries. * Ovarian endometriosis. * Medical or gynecological conditions that may affect ovarian response to controlled ovarian stimulation. * Indication for luteinizing hormone (LH) supplementation during controlled ovarian stimulation. * Poor sperm quality, cryptozoospermia, surgically retrieved sperm (PESA, TESE, or microTESE), cryopreserved sperm, or donor sperm. * Indication for artificial oocyte activation (AOA) or rescue ICSI (R-ICSI).
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What it tests

  • Follitropin Alfa (Follitrope)
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Where

1 site
An Sinh Hospital
Ho Chi Minh City, Vietnam
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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