Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-30 @ 11:48 AM
Study NCT ID:
NCT06293235
Status:
RECRUITING
Last Update Posted:
2024-10-09
First Post:
2024-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Towards Optimal Fertility, Fathering and Fatherhood studY
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055101', 'term': 'Semen Analysis'}, {'id': 'D020816', 'term': 'Amino Acid Motifs'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000072416', 'term': 'Protein Structural Elements'}, {'id': 'D011487', 'term': 'Protein Conformation'}, {'id': 'D008968', 'term': 'Molecular Conformation'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D017433', 'term': 'Protein Structure, Secondary'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 960}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-02-27', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sperm morphology', 'timeFrame': 'Up to 2 years', 'description': 'Assessed by semen analysis'}], 'primaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': 'Up to 16 weeks of gestation', 'description': 'Defined by viable intrauterine pregnancy at gestational weeks of less or equal to 16 at the time of the study'}], 'secondaryOutcomes': [{'measure': 'Fertility index', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'Defined by a composite index score derived from both male and female predictive factors'}, {'measure': 'Oxidative stress', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'Defined by oxidative status measured from blood and semen samples using the micro-NMR'}, {'measure': 'Semen volume', 'timeFrame': 'Up to 2 years', 'description': 'Assessed by semen analysis in ml'}, {'measure': 'Sperm concentration', 'timeFrame': 'Up to 2 years', 'description': 'Assessed by semen analysis in million/ml'}, {'measure': 'Sperm total motility', 'timeFrame': 'Up to 2 years', 'description': 'Assessed by semen analysis in percent'}, {'measure': 'Sperm progressive motility', 'timeFrame': 'Up to 2 years', 'description': 'Assessed by semen analysis in percent'}, {'measure': 'Total progressive motile sperm count', 'timeFrame': 'Up to 2 years', 'description': 'measured by multiplying the semen volume (ml) by sperm concentration (million/ml) and the percentage of progressively motile sperm'}, {'measure': 'Single strand sperm DNA fragmentation', 'timeFrame': 'Up to 2 years', 'description': 'Measured by the AI-powered semen analyzer'}, {'measure': 'Double strand sperm DNA fragmentation', 'timeFrame': 'Up to 2 years', 'description': 'Measured by the AI-powered semen analyzer'}, {'measure': 'mRNA level', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'From blood and semen samples through transcriptomics analysis'}, {'measure': 'sncRNA level', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'From blood and semen samples through transcriptomics analysis'}, {'measure': 'DNA methylation', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'From blood and semen samples through bisulfite sequencing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Male', 'Risk factor', 'Lifestyle', 'Semen analysis', 'Epigenetic', 'Oxidative stress', 'DNA fragmentation'], 'conditions': ['Reproductive Issues', 'Fertility Issues']}, 'referencesModule': {'references': [{'pmid': '39819913', 'type': 'DERIVED', 'citation': 'Ku CW, Pek JW, Cheung YB, Tharmalingam Durgahshree MD, Chan M, Lee YH, Godfrey K, Yap F, Chan JKY, Loy SL. Investigating male factors and their relationships with reproductive health outcomes: a case-control study protocol for Towards Optimal Fertility, Fathering, and Fatherhood studY (TOFFFY) in Singapore. BMJ Open. 2025 Jan 15;15(1):e088143. doi: 10.1136/bmjopen-2024-088143.'}]}, 'descriptionModule': {'briefSummary': 'This case-control study involving fertile and subfertile couples aims to identify male factors related to pregnancy likelihood, create a fertility index measure combining male and female factors to predict pregnancy likelihood, and examine how male factors relate to the semen physical and biological characteristics.', 'detailedDescription': "Paternal contributions to fertility and reproductive health outcomes have been understudied, despite promising evidence from animal studies. This study aims to investigate the male contribution to pregnancy likelihood and explore the underlying biological mechanisms. Specifically, the investigators aim to (1) identify male factors associated with pregnancy rate; (2) develop a fertility index combining modifiable factors for both males and females to predict pregnancy rate; and (3) explore the relationship of male modifiable factors with semen physical and molecular characteristics. This is a case-control study with 480 fertile and subfertile males (along with their female partners), recruited from KK Women's and Children's Hospital. The investigators will use questionnaires to collect data on socio-demographic characteristics, clinical, lifestyle, and environmental factors; analyze metabolic and stress biomarkers from blood samples; and measure semen parameters including sperm motility, density, morphology, volume, DNA fragmentation, DNA methylation, gene expression, and seminal plasma oxidative status. Findings from this proposed study will pave the way for developing lifestyle-based or medical interventions to enhance male and couple reproductive health, and potentially benefiting future offspring health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '21 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subfertile couples will be recruited from the infertility clinics, while the fertile couples will be recruited from the antenatal clinics. Both groups will also be recruited from on-going preconception and pregnancy programs in the hospital.', 'genderDescription': 'Based on biological sex identity for males and females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubfertile couples:\n\n* men aged ≥21-49 years\n* men with a female partner aged 21-39 years\n* couples who are not able to conceive for at least 12 months\n* couples who are Singapore citizen or permanent resident\n\nFertile couples:\n\n* men aged 21-49 years\n* men with a female partner aged 21-39 years\n* men with proven fertility defined as those female partners who are currently pregnant and with viable intrauterine pregnancy at gestational weeks of less or equal to 16 at the time of the study\n* couples with attempted time to conceive within 12 months to achieve this pregnancy or with unplanned pregnancy\n* couples who are Singapore citizen or permanent resident\n\nExclusion Criteria:\n\nSubfertile couples:\n\n* male infertility of a known aetiology including azoospermia, retrograde ejaculation, genetic disorders, cancer treatment, or testes trauma\n* female infertility diagnosis as confirmed by diagnostic imaging or having severe endometriosis\n* female partners with irregular menstrual cycle \\>35 days\n* couples with known chromosomal abnormalities\n\nFertile couples:\n\n* couples who achieve pregnancy after oocyte or spermatozoa donation\n* couples with known chromosomal abnormalities\n* female partners with known uterine abnormalities'}, 'identificationModule': {'nctId': 'NCT06293235', 'acronym': 'TOFFFY', 'briefTitle': 'Towards Optimal Fertility, Fathering and Fatherhood studY', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'Investigating Male Factors and Their Relationships With Reproductive Health Outcomes in Singapore: Towards Optimal Fertility, Fathering and Fatherhood studY', 'orgStudyIdInfo': {'id': '2024/2120'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subfertile couples', 'description': 'Couples who are not able to conceive for at least 12 months with female partners without infertility diagnosis.', 'interventionNames': ['Other: Lifestyle and metabolic indicators']}, {'label': 'Fertile couples', 'description': 'Couples with attempted time to conceive within 12 months to achieve this pregnancy or with unplanned pregnancy, with female partners who are currently pregnant with viable intrauterine pregnancy.', 'interventionNames': ['Other: Lifestyle and metabolic indicators']}], 'interventions': [{'name': 'Lifestyle and metabolic indicators', 'type': 'OTHER', 'otherNames': ['Semen quality and characteristics'], 'description': 'Socio-demographics, health history, behavioural characteristics, environmental exposures, anthropometric measurements, body fat composition, metabolic and stress biomarkers, semen physical and molecular characteristics.', 'armGroupLabels': ['Fertile couples', 'Subfertile couples']}]}, 'contactsLocationsModule': {'locations': [{'zip': '229899', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Benjarat Oh', 'role': 'CONTACT', 'email': 'benjarat.oh@kkh.com.sg', 'phone': '+6583684641'}], 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Benjarat Oh', 'role': 'CONTACT', 'email': 'benjarat.oh@kkh.com.sg', 'phone': '63948105', 'phoneExt': '65'}], 'overallOfficials': [{'name': 'See Ling Loy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "KK Women's and Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}