protocolSection identificationModule nctId: NCT06378268, orgStudyIdInfo id: 05/24/DD-BVMD, briefTitle: PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study), acronym: ProGanOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Mỹ Đức Hospital, class: OTHER, descriptionModule briefSummary: This non-inferiority randomized controlled trial will be conducted at My Duc Hospital, Ho Chi Minh City, Vietnam.This study compares the effectiveness of Progestin-Primed Ovarian stimulation versus GnRH protocol for ovarian stimulation in IVF treatment. Participants will be randomly assigned in a 1:1 ratio to receive Progestins or GnRH antagonists., conditionsModule conditions: Progestins Primed Ovarian Stimulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 626, type: ESTIMATED, armsInterventionsModule interventions name: Dydrogesterone 10 mg, interventions name: Cetrorelix 0.25 mg, outcomesModule primaryOutcomes measure: Ongoing pregnancy, secondaryOutcomes measure: The incidence of premature LH surge, secondaryOutcomes measure: The incidence of premature progesterone elevation, secondaryOutcomes measure: Number of oocytes retrieved, secondaryOutcomes measure: Number of mature oocytes, secondaryOutcomes measure: Number of day 3 embryos, secondaryOutcomes measure: Number of day 5 embryos, secondaryOutcomes measure: Number of good quality day 3 embryos, secondaryOutcomes measure: Number of good quality day 5 embryos, secondaryOutcomes measure: Number of frozen embryos, secondaryOutcomes measure: Incidence of Ovarian hyperstimulation syndrome, secondaryOutcomes measure: Positive ß-hCG test, secondaryOutcomes measure: Clinical pregnancy, secondaryOutcomes measure: Ectopic pregnancy, secondaryOutcomes measure: Early miscarriage <12 weeks, secondaryOutcomes measure: Late miscariage 12-< 22 weeks, secondaryOutcomes measure: Live birth rate, secondaryOutcomes measure: Gestational age at birth, secondaryOutcomes measure: Mode of delivery, secondaryOutcomes measure: Birth weight, secondaryOutcomes measure: Very low birth weight, secondaryOutcomes measure: Low birth weight, secondaryOutcomes measure: High birth weight, secondaryOutcomes measure: Very high birth weight, secondaryOutcomes measure: Preterm birth, secondaryOutcomes measure: Gestational diabetes mellitus, secondaryOutcomes measure: Hypertensive disorders of pregnancy, secondaryOutcomes measure: Maternal mortality, secondaryOutcomes measure: Major congenital abnormalities, secondaryOutcomes measure: NICU admission, secondaryOutcomes measure: Reason for NICU admission, secondaryOutcomes measure: Neonatal mortality, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: My Duc Hospital, status: RECRUITING, city: Ho Chi Minh City, zip: 70000, country: Vietnam, contacts name: Tuong M Ho, MD, role: CONTACT, phone: +84 90 3633377, email: tuongho.ivfmd@gmail.com, geoPoint lat: 10.82302, lon: 106.62965, hasResults: False