Ejaculation Frequency and Semen Parameters

Fertility Clinical Trial

— EFASP  

Official title:

Effect of Male Ejaculation Frequency on Semen Parameters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172504
• Other study ID #: 2023-HS-134
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Fertility
• Sperm

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