Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT06561958
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2024-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings
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': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2024-08-06', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative live birth rate', 'timeFrame': 'Up to 12 months', 'description': 'Cumulative live birth rate defined as delivery of at least 1 live fetus after 20 completed weeks of gestation, combined fresh and frozen embryo transfers within 12 months after the start of the ovarian stimulation in patients of the first REKOVELLE ovarian stimulation cycle.'}], 'secondaryOutcomes': [{'measure': 'The Luteinising hormone (LH) surge suppression protocol', 'timeFrame': 'Up to 22 days', 'description': 'Treatment pattern will be measured by analysing the Lutenising hormone (LH) surge suppression protocol.'}, {'measure': 'Daily Dosage', 'timeFrame': 'Up to 22 days', 'description': 'Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of daily dosage.'}, {'measure': 'Stimulation Duration', 'timeFrame': 'Up to 22 days', 'description': 'Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of stimulation duration.'}, {'measure': 'Total Dosage', 'timeFrame': 'Up to 22 days', 'description': 'Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of total dosage.'}, {'measure': 'Trigger Protocol', 'timeFrame': 'Up to 22 days', 'description': 'Treatment pattern will be measured by analysing the trigger protocol.'}, {'measure': 'Luteal phase support protocol', 'timeFrame': 'Up to 22 days', 'description': 'Treatment pattern will be measured by analysing the luteal phase support protocol.'}, {'measure': 'Number of oocytes retrieved', 'timeFrame': 'Up to 22 days', 'description': 'Number of oocytes retrieved at oocyte retrieval'}, {'measure': 'Number of Metaphase II (MII) oocytes', 'timeFrame': 'Up to 22 days', 'description': 'Number of MII oocytes at oocyte retrieval (only applicable for Intracytoplasmic sperm injection (ICSI))'}, {'measure': 'Number of embryos', 'timeFrame': 'Day 3 after oocyte retrieval', 'description': 'Number of embryos on Day 3 after oocyte retrieved'}, {'measure': 'Number of Blastocysts', 'timeFrame': 'Day 5 after oocyte retrieval', 'description': 'Number of Blastocysts on Day 5 after oocyte retrieved'}, {'measure': 'Number of embryos transferred', 'timeFrame': 'Up to 28 days', 'description': 'Embryos transferred in fresh and/or frozen transfer cycles'}, {'measure': 'Number of blastocysts transferred', 'timeFrame': 'Up to 28 days', 'description': 'Blastocysts transferred in fresh and/or frozen transfer cycles'}, {'measure': 'Implantation rate', 'timeFrame': 'Up to 28 days', 'description': 'Number of gestational sacs, embryos or blastocysts transferred'}, {'measure': 'Positive human chorionic gonadotropin (hCG) rate', 'timeFrame': '11 to 15 days after transfer', 'description': 'Positive human chorionic gonadotropin (hCG) rate analysed using serum or urine hCG test 11-15 days after transfer'}, {'measure': 'Clinical Pregnancy rate', 'timeFrame': '4 to 5 weeks after transfer', 'description': 'Clinical pregnancy rate (at least 1 gestational sac 4-5 weeks after transfer)'}, {'measure': 'Vital Pregnancy', 'timeFrame': '4 to 5 weeks after transfer', 'description': 'Vital pregnancy rate (at least 1 intrauterine gestational sac with fetal heartbeat 4-5 weeks after transfer)'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '9 to 11 weeks after transfer', 'description': 'Ongoing pregnancy rate (at least 1 intrauterine viable fetus 9-11 weeks after transfer)'}, {'measure': 'Time to pregnancy', 'timeFrame': '4 to 5 weeks after transfer', 'description': 'Time to pregnancy from start date of ovarian stimulation to confirmation of clinical pregnancy'}, {'measure': 'Live birth rate', 'timeFrame': 'More than 20 weeks after transfer', 'description': 'Live birth is defined as delivery of at least 1 live fetus after 20 completed weeks of gestation within 12 months after the start of the ovarian stimulation in patients of the first REKOVELLE ovarian stimulation cycle.'}, {'measure': 'Multiple pregnancy rate', 'timeFrame': '4 to 5 weeks after transfer', 'description': 'More than 1 gestational sac with fetal heart beat 4-5 weeks after transfer'}, {'measure': 'Spontaneous abortion rate', 'timeFrame': 'Up to 10-11 weeks after transfer', 'description': 'Spontaneous abortion is defined as positive hCG test but all intrauterine gestational sacs without fetal heart beat as documented by ultrasound, or there are no viable fetuses observed by ultrasound'}, {'measure': 'Ectopic pregnancy rate', 'timeFrame': 'Up to 10-11 weeks after transfer', 'description': 'Ectopic pregnancy is defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery.'}, {'measure': 'Estradiol Hormone levels', 'timeFrame': 'Up to 20 days', 'description': 'Estradiol hormone levels before stimulation and at the end of stimulation day'}, {'measure': 'Progesterone Hormone levels', 'timeFrame': 'Up to 20 days', 'description': 'Progesterone hormone levels before stimulation and at the end of stimulation day'}, {'measure': 'Cycle cancellation rate and the reason for cycle cancellation', 'timeFrame': 'Up to 28 days', 'description': 'Date when the investigator decides to cancel cycle before oocyte pick up (due to poor ovarian response, excessive ovarian response, any illness which prevents oocyte collection procedure, subject not taking hCG injection at the correct time, subject choice, other) or after oocyte pick-up (due to no oocytes collected, no oocytes fertilized, abnormal fertilization, abnormal embryo development, no embryo development, ovarian hyperstimulation syndrome (OHSS), subject choice, any other specified reason)'}, {'measure': 'Transfer cancellation rate and the reason for transfer cancellation', 'timeFrame': 'Up to 28 days', 'description': 'Transfer cancellation rate and the reason for transfer cancellation (no embryo available for transfer, risk of OHSS, endometrium not receptive, high progesterone level, adverse event, any other specified reason for transfer cancellation).'}, {'measure': 'Frequency and severity of adverse drug reactions (ADRs) and serious adverse events (SAEs)', 'timeFrame': 'During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer', 'description': 'Frequency and severity of ADRs and SAEs as defined by the investigator'}, {'measure': 'Preventive interventions for 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.', 'description': 'Preventive interventions decided by the investigator (Triggering of final follicular maturation with GnRH agonist and fresh embryo/blastocyst transfer or cryopreservation, Cancellation of fresh embryo/blastocyst transfer)'}, {'measure': 'Number of subjects with mild / moderate / severe 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', 'description': 'Number of subjects with mild / moderate / severe OHSS, defined by the investigator'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 1500 patients prescribed REKOVELLE for the first time for controlled overian stimulation (COS) will be enrolled in the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females aged 20 years or older at enrollment\n* Serum AMH level \\>0.5 ng / mL (with the latest result tested within 12 months)\n* Who are first time prescribed REKOVELLE for their ovarian stimulation and IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor (if applicable)\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Have undergone more than 2 COS-IVF / ICSI cycles before the enrollment\n* Participating in an interventional clinical trial in which any medication treatment is mandated\n* Women with a contraindication for prescription of REKOVELLE treatment\n* Oocyte donors\n* Undergoing ovarian stimulation for fertility preservation'}, 'identificationModule': {'nctId': 'NCT06561958', 'acronym': 'PROFOUND', 'briefTitle': 'Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Prospective, Multi-country, Non-Interventional Study to Investigate REKOVELLE for Ovarian Stimulation: the Effectiveness, Safety, and Patterns Of Use for Asian Women in Real World Practice', 'orgStudyIdInfo': {'id': '000430'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'REKOVELLE', 'description': 'Participants prescribed REKOVELLE for the first time for controlled ovarian stimulation.', 'interventionNames': ['Drug: REKOVELLE']}], 'interventions': [{'name': 'REKOVELLE', 'type': 'DRUG', 'description': 'Individualised dosing regiment of REKOVELLE in routine clinical practice.', 'armGroupLabels': ['REKOVELLE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2610023', 'city': 'Chiba', 'state': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '8120013', 'city': 'Fukuoka', 'state': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '8070825', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '3700841', 'city': 'Takasaki', 'state': 'Gunma', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'zip': '7320822', 'city': 'Hiroshima', 'state': 'Hiroshima', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '1130033', 'city': 'Bunkyō City', 'state': 'Japan', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'zip': '1600023', 'city': 'Tokyo', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '7300035', 'city': 'Hiroshima', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '0600003', 'city': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site'}, {'zip': '6500021', 'city': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '5300011', 'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '5500015', 'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '3540035', 'city': 'Saitama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '49241', 'city': 'Busan', 'state': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '41910', 'city': 'Daegu', 'state': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '13496', 'city': 'Seongnam-si', 'state': 'Seongnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '47245', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '02586', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Maria Fertility Hospital', 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'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '100225', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '110', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'Disclosure@ferring.com'}], 'facility': 'Ferring Investigational Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '65000', 'city': 'Phitsanulok', 'state': 'Muang', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Naresuan University Hospital', 'geoPoint': {'lat': 16.82481, 'lon': 100.25858}}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Ratchathewi', 'status': 'RECRUITING', 'country': 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