Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT06172504
Status:
UNKNOWN
Last Update Posted:
2023-12-15
First Post:
2023-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ejaculation Frequency and Semen Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2023-12-14', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of ejaculation frequency on sperm DNA fragmentation rate', 'timeFrame': '6 months', 'description': 'The subjects abstained for 3-7 days and masturbated to collect semen for measurement of sperm DNA fragment rate. Survey the basic information of the subjects and their frequency of ejaculation in the past month.The frequency of ejaculation was divided into four groups:(1) 0-4 times/month; (2) 5-8 times/month; (3) 8-12 times/month; (4) \\>12 times/month. The outcome was to compare whether there were differences in semen parameters between the groups'}, {'measure': 'Effect of ejaculation frequency on sperm motility rate', 'timeFrame': '6 months', 'description': 'The subjects abstained for 3-7 days and masturbated to collect semen for measurement of sperm motility rate. Survey the basic information of the subjects and their frequency of ejaculation in the past month. The frequency of ejaculation was divided into four groups:(1) 0-4 times/month; (2) 5-8 times/month; (3) 8-12 times/month; (4) \\>12 times/month. The outcome was to compare whether there were differences in semen parameters between the groups'}, {'measure': 'Effect of ejaculation frequency on total sperm count', 'timeFrame': '6 months', 'description': 'The subjects abstained for 3-7 days and masturbated to collect semen for measurement of total sperm count. Survey the basic information of the subjects and their frequency of ejaculation in the past month. The frequency of ejaculation was divided into four groups:(1) 0-4 times/month; (2) 5-8 times/month; (3) 8-12 times/month; (4) \\>12 times/month. The outcome was to compare whether there were differences in semen parameters between the groups'}, {'measure': 'Effect of ejaculation frequency on sperm vitality rate', 'timeFrame': '6 months', 'description': 'The subjects abstained for 3-7 days and masturbated to collect semen for measurement of sperm vitality rate. Survey the basic information of the subjects and their frequency of ejaculation in the past month. The frequency of ejaculation was divided into four groups:(1) 0-4 times/month; (2) 5-8 times/month; (3) 8-12 times/month; (4) \\>12 times/month. The outcome was to compare whether there were differences in semen parameters between the groups'}, {'measure': 'Effect of ejaculation frequency on sperm morphology', 'timeFrame': '6 months', 'description': 'The subjects abstained for 3-7 days and masturbated to collect semen for measurement of sperm morphology. Survey the basic information of the subjects and their frequency of ejaculation in the past month. The frequency of ejaculation was divided into four groups:(1) 0-4 times/month; (2) 5-8 times/month; (3) 8-12 times/month; (4) \\>12 times/month. The outcome was to compare whether there were differences in semen parameters between the groups'}], 'secondaryOutcomes': [{'measure': 'Effect of the penultimate abstinence period on DNA fragmentation rate', 'timeFrame': '6 months', 'description': 'The subjects abstained for 3-7 days and masturbated to collect semen for measurement of sperm morphology. Survey the basic information of the subjects and their penultimate abstinence period. The outcome was to compare whether the penultimate abstinence period had an effect on DNA fragmentation rate（the cutoff value is 15%). We plans to recruit more than 1000 subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Semen Parameters', 'Ejaculation Frequency', 'the penultimate abstinence period'], 'conditions': ['Sperm', 'Fertility']}, 'referencesModule': {'references': [{'pmid': '28760517', 'type': 'BACKGROUND', 'citation': 'Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, Rienzi L, Sunde A, Schmidt L, Cooke ID, Simpson JL, van der Poel S. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017 Sep;108(3):393-406. doi: 10.1016/j.fertnstert.2017.06.005. Epub 2017 Jul 29.'}, {'pmid': '29555319', 'type': 'BACKGROUND', 'citation': 'Vander Borght M, Wyns C. Fertility and infertility: Definition and epidemiology. Clin Biochem. 2018 Dec;62:2-10. doi: 10.1016/j.clinbiochem.2018.03.012. Epub 2018 Mar 16.'}, {'pmid': '32330362', 'type': 'BACKGROUND', 'citation': 'Leisegang K, Dutta S. Do lifestyle practices impede male fertility? Andrologia. 2021 Feb;53(1):e13595. doi: 10.1111/and.13595. Epub 2020 Apr 24.'}, {'pmid': '29143943', 'type': 'BACKGROUND', 'citation': 'Hanson BM, Aston KI, Jenkins TG, Carrell DT, Hotaling JM. The impact of ejaculatory abstinence on semen analysis parameters: a systematic review. J Assist Reprod Genet. 2018 Feb;35(2):213-220. doi: 10.1007/s10815-017-1086-0. Epub 2017 Nov 16.'}, {'pmid': '36555920', 'type': 'BACKGROUND', 'citation': 'Barbagallo F, Cannarella R, Crafa A, Manna C, La Vignera S, Condorelli RA, Calogero AE. The Impact of a Very Short Abstinence Period on Conventional Sperm Parameters and Sperm DNA Fragmentation: A Systematic Review and Meta-Analysis. J Clin Med. 2022 Dec 8;11(24):7303. doi: 10.3390/jcm11247303.'}, {'pmid': '12468181', 'type': 'BACKGROUND', 'citation': 'Stanford JB, White GL, Hatasaka H. Timing intercourse to achieve pregnancy: current evidence. Obstet Gynecol. 2002 Dec;100(6):1333-41. doi: 10.1016/s0029-7844(02)02382-7.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to determine whether the frequency of ejaculation in men had an effect on semen parameters.. The main questions it aims to answer are:\n\n* question 1：Whether the frequency of ejaculation has an effect on semen parameters\n* question 2：Whether the penultimate abstinence period has an effect on semen parameters\n\nThe participants were men who underwent semen examination in the andrology clinic of the Reproductive Center of the First Hospital of Jilin University. A brief medical history was collected from each volunteer, including demographic information, fertility history and as well as information regarding their general health.The focus of the investigation is the time of abstinence for this examination, the penultimate abstinence period, and the number of ejaculation since the last 1 month.', 'detailedDescription': 'The main subjects of this study were husbands who underwent semen examination, Including pre-conception, infertility, and his wife with a history of pregnancy loss. Before the examination, the basic information such as age, height, weight, smoking, drinking, infertility years, fertility and pregnancy history, marriage years, education, occupation and exclusion criteria have adverse effects on sperm were investigated.The focus of the investigation is the time of abstinence for this examination, the penultimate abstinence period, and the number of ejaculation since the last 1 month. According to World Health Organization standards, semen analysis requires abstinence for 48h to 7 days. Semen parameters were recorded, including sperm DNA fragmentation rate, sperm motility rate, total sperm count, sperm motility, and sperm morphology. The frequency of ejaculation was divided into four groups:(1)0-4 times/month;(2)5-8 times/month;(3) 8-12 times/month;(4) \\>12 times/month.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants were men who underwent semen examination in the andrology clinic of the Reproductive Center of the First Hospital of Jilin University. Including pre-conception, infertility, and his wife with a history of pregnancy loss.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Normal ejaculation function, normal sexual life, masturbation can ejaculate\n2. Male age between 22 and 45 years old.\n3. According to World Health Organization standards, the semen examination time is within 48h to 7 days of abstinence.\n\nExclusion Criteria:\n\n1. The man was diagnosed with extremely severe oligospermia (sperm concentration \\<1 million/ml) and azoospermia.\n2. Identify the factors affecting semen parameters, long-term exposure to high temperature, long-term exposure to chemicals, heavy metals, radiation and other toxic and harmful substances, orchitis/epididymitis, cryptorchidism, radiotherapy and chemotherapy treatment, and taking drugs to improve sperm within three months'}, 'identificationModule': {'nctId': 'NCT06172504', 'acronym': 'EFASP', 'briefTitle': 'Ejaculation Frequency and Semen Parameters', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Effect of Male Ejaculation Frequency on Semen Parameters', 'orgStudyIdInfo': {'id': '2023-HS-134'}}, 'contactsLocationsModule': {'locations': [{'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yang yu, doctor', 'role': 'CONTACT', 'email': 'yuyang0351@jlu.edu.cn', 'phone': '+86 13844000361'}], 'facility': 'the first hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'yang yu, doctor', 'role': 'CONTACT', 'email': 'yuyang0351@jlu.edu.cn', 'phone': '+86 13844000361'}], 'overallOfficials': [{'name': 'yang yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}