Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:50 AM
Study NCT ID:
NCT07409493
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blastocyst formation rate', 'timeFrame': 'Day 5 to Day 6 after oocyte retrieval', 'description': 'Number of high-quality blastocysts (grade ≥ 3BB) obtained per cycle'}], 'secondaryOutcomes': [{'measure': 'Embryo morphokinetic development', 'timeFrame': 'Day 2 to day 5 after oocyte retrieval', 'description': 'Compare the embryomorphokinetic milestones evaluated using the time-lapse evaluation system (EmbryoScope+ Vitrolife).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IVF', 'PPOS', 'Embryo morphokinetics'], 'conditions': ['Infertility (IVF Patients)', 'Embryo Morphokinetics', 'Progestins Primed Ovarian Stimulation']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare two ovarian stimulation protocols used in in vitro fertilization (IVF): the fixed Progestin-Primed Ovarian Stimulation (PPOS) protocol and the GnRH Antagonist protocol. The study will evaluate IVF outcomes and embryo development patterns using time-lapse embryo monitoring technology. The main questions the study aims to answer are:\n\n* Does the fixed - PPOS protocol achieve similar numbers of mature eggs, good-quality embryos, and clinical outcomes compared to the GnRH Antagonist protocol?\n* Are there differences in embryo development patterns (morphokinetics) between the two protocols when monitored by time-lapse imaging?\n* How does embryo quality (KIDScore) compare between the two protocols?\n\nStudy Design:\n\nResearchers will randomly assign 148 women undergoing IVF to two groups:\n\n* PPOS group (n=74): Will receive FSH injections (oral Duphaston 20mg daily) starting from day 2-3 of the menstrual cycle\n* GnRH Antagonist group (n=74): Will receive FSH injections (Orgalutran 0.25mg injections) when follicles reach ≥14mm\n\nParticipants will:\n\n* Undergo controlled ovarian stimulation with their assigned protocol for approximately 10-12 days\n* Have regular ultrasound monitoring and blood tests to track follicle development\n* Undergo egg retrieval procedure when follicles are mature\n* Have all embryos cultured in the EmbryoScope time-lapse incubator with continuous monitoring\n* Have embryos frozen on Day 5/6 for future transfer\n\nStudy Location:\n\nDepartment of Assisted Reproduction and Andrology, Hanoi Obstetrics and Gynecology Hospital\n\nStudy Duration: January 2026 - June 2028'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 20-45 years\n* Indicated for in vitro fertilization (IVF) treatment\n* Planned freeze-all embryo strategy\n* Voluntary participation in research.\n\nExclusion Criteria:\n\n* Systemic diseases\n* Use of hormonal medications within 3 months prior to enrollment\n* Oocyte donation cycles\n* Unwilling or unable to participate in research'}, 'identificationModule': {'nctId': 'NCT07409493', 'briefTitle': 'IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols', 'organization': {'class': 'OTHER', 'fullName': 'Hanoi Medical University'}, 'officialTitle': 'IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols', 'orgStudyIdInfo': {'id': 'HMUIRB2275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PPOS protocol', 'description': 'FSH + Dydrogesterone 20mg/day from day 2 - 3 of the menstrual cycle. Optional LH supplementation. Freeze-all with time-lapse monitoring.', 'interventionNames': ['Drug: Progestin-Primed Ovarian Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antagonist protocol', 'description': 'FSH + Orgalutran 0.25 mg/day (starting when follicle ≥12 mm). Optional LH supplementation. Freeze-all with time-lapse monitoring.', 'interventionNames': ['Drug: Antagonist protocol for IVF']}], 'interventions': [{'name': 'Progestin-Primed Ovarian Stimulation', 'type': 'DRUG', 'description': 'Ovarian stimulation using progestin-primed ovarian stimulation (PPOS) protocol. Patients receive recombinant FSH starting from day 2-3 of menstrual cycle, concomitantly with oral Dydrogesterone 20mg daily to prevent premature LH surge. All embryos are cultured using time-lapse technology and cryopreserved for subsequent frozen embryo transfer.', 'armGroupLabels': ['PPOS protocol']}, {'name': 'Antagonist protocol for IVF', 'type': 'DRUG', 'description': 'Ovarian stimulation using GnRH antagonist protocol. Patients receive recombinant FSH starting from day 2-3 of menstrual cycle. GnRH antagonist is added when leading follicle reaches 12-14mm diameter to prevent premature LH surge. All embryos are cultured using time-lapse technology and cryopreserved for subsequent frozen embryo transfer.', 'armGroupLabels': ['Antagonist protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Hanoi', 'status': 'RECRUITING', 'country': 'Vietnam', 'facility': 'Hanoi Obstetrics and Gynecology Hospital', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'centralContacts': [{'name': 'Thanh Huy Dao, MD', 'role': 'CONTACT', 'email': 'huythanhdao.hmu@gmail.com', 'phone': '+84 971597096'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanoi Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hanoi Obstetrics and Gynecology Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}