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SpermEFASPNCT06172504

Ejaculation Frequency and Semen Parameters

An observational study of Sperm and Fertility, run by The First Hospital of Jilin University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 22 to 45 years, men only
Conditions the study is for
Sperm, Fertility
How many people
1,500 participants
Where
1 siteChina
Study dates
11 Nov 2023to Nov 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 45 years
  • Men only
  • Adult

Study population: 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.

Who may be able to join

  • Normal ejaculation function, normal sexual life, masturbation can ejaculate
  • Male age between 22 and 45 years old.
  • According to World Health Organization standards, the semen examination time is within 48h to 7 days of abstinence.

Who cannot join

  • The man was diagnosed with extremely severe oligospermia (sperm concentration <1 million/ml) and azoospermia.
  • 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

Trial locations and contacts

1 site in 1 country.

yang yu, doctor contact

+86 13844000361

yuyang0351@jlu.edu.cn

China1 site, 1 recruiting

  • the first hospital of Jilin University

    Changchun, Jilin, 130000

    yang yu, doctor, +86 13844000361, yuyang0351@jlu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Effect of Male Ejaculation Frequency on Semen Parameters

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.

Read the detailed 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.

Conditions
Sperm, Fertility
Keywords
Semen Parameters, Ejaculation Frequency, the penultimate abstinence period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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

    Measured: 6 months

  5. 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

    Measured: 6 months

Secondary outcomes (1)

  1. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2023
  2. Study start11 Nov 2023
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06172504
Sponsor's protocol ID
2023-HS-134
Acronym
EFASP
Status last verified
Nov 2023
First submitted
21 Nov 2023
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28760517

  • 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.

    PubMed 29555319

  • 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.

    PubMed 32330362

  • 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.

    PubMed 29143943

  • 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.

    PubMed 36555920

  • 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.

    PubMed 12468181

Questions about this trial

What is this clinical trial studying?

An observational study of Sperm and Fertility, run by The First Hospital of Jilin University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact yang yu, doctor (+86 13844000361, yuyang0351@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of ejaculation frequency on sperm DNA fragmentation rate (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06172504, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.

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