Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT07029451
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live Birth Rate per initiated stimulation cycles', 'timeFrame': 'Up to 15 months'}], 'secondaryOutcomes': [{'measure': 'Serum oestradiol levels', 'timeFrame': 'Up to 20 days', 'description': 'Serum oestradiol levels on days of stimulation initiation (before treatment) and at end-of-stimulation'}, {'measure': 'Progesterone (P4) levels', 'timeFrame': 'Up to 20 days', 'description': 'Progesterone (P4) levels on days of stimulation initiation (before treatment) and at end-of-stimulation'}, {'measure': 'Cycle cancellation rate and reasons for cycle cancellation', 'timeFrame': 'Up to 28 days'}, {'measure': 'Number of oocytes retrieved', 'timeFrame': 'Up to 22 days'}, {'measure': 'Number of metaphase II (MII) oocytes', 'timeFrame': 'Up to 22 days', 'description': 'Number of metaphase II (MII) oocytes for intracytoplasmic sperm injection (ICSI)'}, {'measure': 'Number of embryos on Day 3 after oocyte retrieval', 'timeFrame': 'Day 3 after oocyte retrieval'}, {'measure': 'Number of embryos on Day 5 after oocyte retrieval', 'timeFrame': 'Day 5 after oocyte retrieval'}, {'measure': 'Number of transferred embryos', 'timeFrame': 'Up to 28 days'}, {'measure': 'Number of transferred blastocysts', 'timeFrame': 'Up to 28 days'}, {'measure': 'Transfer cancellation rate and reasons for transfer cancellation', 'timeFrame': 'Up to 28 days'}, {'measure': 'Implantation rate', 'timeFrame': 'Up to 28 days', 'description': 'Number of gestational sacs, embryos or blastocysts transferred'}, {'measure': 'Positive beta-human chorionic gonadotropin (βhCG) test rate', 'timeFrame': '11-15 days after transfer'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '4 to 6 weeks after transfer', 'description': 'At least one intrauterine gestational sac 4-6 weeks after transfer'}, {'measure': 'Vital pregnancy rate', 'timeFrame': '4 to 6 weeks after transfer', 'description': 'At least 1 intrauterine gestational sac with fetal heartbeat 4-6 weeks after transfer'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '9 to 11 weeks after transfer', 'description': 'At least 1 intrauterine viable fetus 9-11 weeks after transfer'}, {'measure': 'Cumulative ongoing pregnancy rate', 'timeFrame': '9 to 11 days'}, {'measure': 'Time to pregnancy', 'timeFrame': '4 to 6 weeks after transfer', 'description': 'Time to pregnancy from stimulation initiation to ongoing pregnancy'}, {'measure': 'Pregnancy loss rate', 'timeFrame': 'Up to 10 - 11 weeks after transfer'}, {'measure': 'Live birth rate per initiated stimulation cycles with fresh transfer cycles', 'timeFrame': 'More than 20 weeks after transfer'}, {'measure': 'Cumulative live birth rate per initiated stimulation cycles', 'timeFrame': 'More than 20 weeks after transfer'}, {'measure': 'Frequency and severity of adverse drug reactions', 'timeFrame': 'During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer'}, {'measure': 'Frequency of preventive interventions for early ovarian hyperstimulation syndrome (OHSS)', 'timeFrame': 'During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer'}, {'measure': 'Frequency of early OHSS', 'timeFrame': 'Up to 9 days after triggering of final follicular maturation'}, {'measure': 'Frequency of late OHSS', 'timeFrame': 'Up to 10-11 weeks after transfer'}, {'measure': 'Use of luteinising hormone (LH) surge suppression protocols', 'timeFrame': 'Up to 22 days'}, {'measure': 'Daily dose of REKOVELLE', 'timeFrame': 'Up to 22 days', 'description': 'Use of REKOVELLE protocol, including daily dose'}, {'measure': 'Total dose of REKOVELLE', 'timeFrame': 'Up to 22 days', 'description': 'Use of REKOVELLE protocol including total dose'}, {'measure': 'Stimulation duration', 'timeFrame': 'Up to 22 days', 'description': 'Stimulation duration following use of REKOVELLE protocol'}, {'measure': 'Use of any other concomitant ovarian stimulation agent, including daily dose, total dose, and stimulation duration', 'timeFrame': 'Up to 22 days'}, {'measure': 'Use of follicle maturation triggering protocol', 'timeFrame': 'Up to 22 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'This is a multi-centre prospective non-interventional trial to assess the pattern of use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice.\n\nThere will be approximately 2500 patients initiated with REKOVELLE® treatment and enrolled in 30-50 sites in China. The total duration of the study will be approximately 35 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women eligible for enrolment in the study are those scheduled for their first REKOVELLE treatment, with no more than one prior COS cycle for IVF or ICSI, and who meet the inclusion and exclusion criteria. Data from approximately 2,500 patients will be collected.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who meet all the following criteria are eligible for participation:\n\n * At least 20 years of age (including the 20th birthday) when signing informed consent\n * Prescribed REKOVELLE for the first time in controlled ovarian stimulation for in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycles\n * Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Women who meet any of the following criteria are not eligible for participation:\n\n * Previously undergone more than 1 controlled ovarian stimulation cycles for IVF or ICSI\n * Currently participating in an interventional clinical study for which treatment with medication is mandated\n * Currently undergoing ovarian stimulation for fertility preservation or oocytes donation\n * Contraindications for the use of REKOVELLE'}, 'identificationModule': {'nctId': 'NCT07029451', 'acronym': 'LYCHEE', 'briefTitle': 'To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Prospective, Post-authorisation, Multi-centre, Non-interventional Study to Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice', 'orgStudyIdInfo': {'id': '000442'}}, 'contactsLocationsModule': {'locations': [{'zip': '300052', 'city': 'Xiaobailou', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital (Heping District)', 'geoPoint': {'lat': 39.11766, 'lon': 117.20565}}, {'zip': '100191', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Peking University Third Hospital (Beijing)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com', 'phone': '+1 862-286-5200'}], 'overallOfficials': [{'name': 'Global Clinical Compliance', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}