protocolSection identificationModule nctId: NCT06367985, orgStudyIdInfo id: 03/24/DD-BVMD, briefTitle: CAPA-IVM Culture With Low Oxygen Tension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mỹ Đức Hospital, class: OTHER, collaborators name: Vrije Universiteit Brussel, descriptionModule briefSummary: Capacitation in-vitro maturation (CAPA-IVM) has recently been advanced in culturing oocytes from the germinal vesicle (GV) stage following mild or no controlled ovarian stimulation. Recent research suggested that O2 concentration may significantly regulate oocyte maturation and early embryo development through hypoxia-inducible factor (HIF). Nonetheless, it has been challenging to create the environmental culture conditions for addressing the optimal number of oocytes and the highest possibility of embryo development since consensus on the oxygen (O2) concentration index in the IVM culture environment has not been reached. Based on the outcomes of atmospheric O2 concentration (20%) and low O2 concentration (5%) during CAPA-IVM culture in mice, it has been hypothesized that a 5% O2 was the optimal culture condition for the pre-IVM step. A 20% O2 was more suitable for the IVM culture step. Therefore, this study is designed to enhance the CAPA-IVM culture system, improving treatment efficiency and providing various benefits for patients undergoing assisted reproductive technology., conditionsModule conditions: In Vitro Fertilization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Sibling oocytes, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Air Oxygen Concentration CAPA-IVM culture, interventions name: Low Oxygen Concentration CAPA-IVM culture, outcomesModule primaryOutcomes measure: Maturation rate, secondaryOutcomes measure: Total number of oocytes retrieval, secondaryOutcomes measure: Number of patients with no oocyte retrieved, secondaryOutcomes measure: Number of MII oocytes, secondaryOutcomes measure: Number of GV oocytes, secondaryOutcomes measure: Number of patients with no matured oocyte, secondaryOutcomes measure: Number of 2PN oocytes, secondaryOutcomes measure: Fertilization rate, secondaryOutcomes measure: Abnormal fertilization rate, secondaryOutcomes measure: Number of patients with no day-3 embryo, secondaryOutcomes measure: Number of day-3 embryos, secondaryOutcomes measure: Number of good quality Day-3 embryos, secondaryOutcomes measure: Number of frozen day-3 embryos, secondaryOutcomes measure: Number of blastocyst (day 5 or day 6 embryo), secondaryOutcomes measure: Number of patients with no blastocyst, secondaryOutcomes measure: Number of good quality blastocysts, secondaryOutcomes measure: Number of frozen blastocysts, secondaryOutcomes measure: Number of embryos transferred, secondaryOutcomes measure: Quality of embryos transferred (Grade 1, Grade 2, Grade 3), secondaryOutcomes measure: Positive pregnancy test rate, secondaryOutcomes measure: Implantation rate, secondaryOutcomes measure: Clinical pregnancy rate, secondaryOutcomes measure: Ectopic pregnancy rate, secondaryOutcomes measure: Ongoing pregnancy rate, secondaryOutcomes measure: Miscarriage <12 weeks rate (Early miscarriage), secondaryOutcomes measure: Miscarriage <22 weeks rate (late miscarriage), secondaryOutcomes measure: Live birth rate, secondaryOutcomes measure: Multiple pregnancy rate, secondaryOutcomes measure: Multiple delivery rate, secondaryOutcomes measure: Mode of delivery, secondaryOutcomes measure: Gestational age at birth, secondaryOutcomes measure: Birth weight, secondaryOutcomes measure: Very low birth weight rate, secondaryOutcomes measure: Low birth weight rate, secondaryOutcomes measure: High birth weight rate, secondaryOutcomes measure: Very high birth weight rate, secondaryOutcomes measure: Small for gestational age rate, secondaryOutcomes measure: Large for gestational age rate, secondaryOutcomes measure: Hypertension in pregnancy rate, secondaryOutcomes measure: Gestational diabetes mellitus rate, secondaryOutcomes measure: Still birth rate, secondaryOutcomes measure: Premature birth rate, secondaryOutcomes measure: Antepartum haemorrhage rate, secondaryOutcomes measure: Major congenital abnormalities rate, secondaryOutcomes measure: Neonatal mortality rate, secondaryOutcomes measure: NICU admission rate, secondaryOutcomes measure: Reason for NICU admission, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 42 Years, stdAges: ADULT, contactsLocationsModule locations facility: My Duc Hospital, city: Ho Chi Minh City, country: Vietnam, contacts name: Tuong M Ho, MSc, MD, role: CONTACT, phone: +84 90 3633377, email: tuongho.ivfmd@gmail.com, geoPoint lat: 10.82302, lon: 106.62965, hasResults: False