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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06172504
Other study ID # 2023-HS-134
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 11, 2023
Est. completion date November 2024

Study information

Verified date November 2023
Source The First Hospital of Jilin University
Contact yang yu, doctor
Phone +86 13844000361
Email yuyang0351@jlu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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: - question 1:Whether the frequency of ejaculation has an effect on semen parameters - question 2:Whether the penultimate abstinence period has an effect on semen parameters The 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers
Gender Male
Age group 22 Years to 45 Years
Eligibility Inclusion Criteria: 1. Normal ejaculation function, normal sexual life, masturbation can ejaculate 2. Male age between 22 and 45 years old. 3. According to World Health Organization standards, the semen examination time is within 48h to 7 days of abstinence. Exclusion Criteria: 1. The man was diagnosed with extremely severe oligospermia (sperm concentration <1 million/ml) and azoospermia. 2. 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China the first hospital of Jilin University Changchun Jilin

Sponsors (1)

Lead Sponsor Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of ejaculation frequency on sperm DNA fragmentation rate 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 6 months
Primary Effect of ejaculation frequency on sperm motility rate 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 6 months
Primary Effect of ejaculation frequency on total sperm count 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 6 months
Primary Effect of ejaculation frequency on sperm vitality rate 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 6 months
Primary Effect of ejaculation frequency on sperm morphology 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 6 months
Secondary Effect of the penultimate abstinence period on DNA fragmentation rate 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. 6 months
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