Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-06 @ 12:12 PM
Study NCT ID:
NCT04068428
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2019-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample will be collected from participants who fail to conceive after 12 months of attempts.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2313}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to pregnancy', 'timeFrame': 'From date of recruitment until the date of last menstrual period when conceived, assessed up to 1 year', 'description': 'Assessed by calculate the intervals between last menstrual period when conceived and the timing of termination of contraception.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of infertility', 'timeFrame': 'After 1 year of follow-up', 'description': 'Infertility was defined according to the World Health Organization manual as failing to achieve pregnancy after at least 12 months of unprotected regular sexual intercourse.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reproductive Health', 'Time to Pregnancy', 'Infertility', 'Risk Factor', 'Assisted Reproductive Technology', 'Prospective Cohort'], 'conditions': ['Reproductive Health', 'Time to Pregnancy', 'Infertility', 'Risk Factor', 'Medical Care']}, 'referencesModule': {'references': [{'pmid': '29030908', 'type': 'BACKGROUND', 'citation': 'Zhou Z, Zheng D, Wu H, Li R, Xu S, Kang Y, Cao Y, Chen X, Zhu Y, Xu S, Chen ZJ, Mol BW, Qiao J. Epidemiology of infertility in China: a population-based study. BJOG. 2018 Mar;125(4):432-441. doi: 10.1111/1471-0528.14966. Epub 2017 Dec 28.'}]}, 'descriptionModule': {'briefSummary': 'This community based prospective cohort study was established to investigate the fecundability of couples of childbearing age. Data are collected regarding age, body mass index, education, menstrual regularity as well as childbearing history. Results of routine examination of leucorrhea, blood glucose, liver function of the female spouse, and semen analysis of the male spouse are obtained from the National Free Pre-conception Check-up Projects (NFPCP) in China. Couples recruited will be followed every 6 months for at least 1 year, and their time to pregnancy as well as behavior of seeking medical care would be recorded. Blood sample and/or information of antral follicle count would be collected from participants who fail to conceive after 12 months of attempts.', 'detailedDescription': "Infertility is a heavy burden on families, with important implications for individuals and public health. In the last decades, the trend of delaying marriage and childbearing has further exacerbated the burden of infertility. From February 2010 to November 2011, a large-scale population-based cross-sectional study was conducted in northern and eastern China. It was reported that the overall prevalence of infertility was 15.5% among women 'at risk' of pregnancy, and 25.0% among women attempting to become pregnant in China. The prevalence of infertility was surprisingly high and aroused our great attention. To further explore the fecundability and associated risk factors in current China, this community based prospective cohort study was established. Recruitment will be performed at cites of National Free Pre-conception Check-up Projects (NFPCP). Besides of the information of sociodemographic characteristics and childbearing history of couples, their results of check-ups will also be obtained. By regular follow-ups, valid data of time to pregnancy will be collected. A prospective cohort would provide an opportunity to reveal the incidence of infertility, and explore the underlying risk factors of infertility, as well as the demand of assisted reproductive technology."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Couples of childbearing age from the cites of National Free Pre-conception Check-up Projects (NFPCP) in city of Guangzhou in Guangdong Province, or the city of Haikou in Hainan Province, will be recruited.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Couples who finish the national free pre-conception check-up\n* Couples who agree to receive follow-ups every half year for at least 1 year\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04068428', 'acronym': 'ReH-CP', 'briefTitle': 'Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou Women and Children's Medical Center"}, 'officialTitle': 'Reproductive Health of Couples of Childbearing Age: a Community Based Prospective Cohort Study', 'orgStudyIdInfo': {'id': '201925201'}}, 'contactsLocationsModule': {'locations': [{'zip': '510623', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangzhou Women and Children's Medical Center", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510623', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Tianhe District Maternal and Child Health Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '570100', 'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'Longhua District Maternal and Child Health Hospital', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'zip': '571100', 'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'Qiongshan District Maternal and Child Health Hospital', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}], 'overallOfficials': [{'name': 'Zehong Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangzhou Women and Children's Medical Center, China"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zehong Zhou', 'investigatorAffiliation': "Guangzhou Women and Children's Medical Center"}}}}