NCT06867627

Brief Summary

The goal of this randomized controlled clinical trial is to investigate the effects of moderate-intensity combined aerobic and resistance exercise on semen quality in Chinese college students. The main question is aim to explore whether moderate-intensity combined aerobic and resistance exercise can improve semen quality. Participants in the intervention group will receive moderate-intensity combined aerobic and resistance exercise three times a week for a period of 12 weeks (The time range is from March 17, 2025 to June 8, 2025. Excluding weekends, Labor Day, and the traditional Chinese Qingming Festival and the Dragon Boat Festival during that period, a total of 32 training sessions are planned). The control group are requested to maintain their normal daily activities. Both groups receive semen routine and serum sex hormones testing before and after the intervention. Researchers will compare the change in semen routine parameters from baseline to post-intervention at 12 weeks between the intervention and control groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 6, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 27, 2025

Last Update Submit

August 2, 2025

Conditions

Keywords

Semen qualityCombined aerobic and resistance exerciseModerate-intensity

Outcome Measures

Primary Outcomes (1)

  • Sperm progressive motility

    Sperm progressive motility and sperm concentration are two major parameters for evaluating semen quality and infertility in males. In the previous one-year prospective intensive follow-up study, basically no sperm concentration among college students was below the WHO standard. In addition, sperm progressive motility is more stable and less susceptible to time and seasonal influences than other semen parameters. Therefore, investigators chose sperm progressive motility as the primary outcome. The computer-assisted sperm analysis (CASA) technology is applied to measure sperm progressive motility. According to the evaluation criteria of the WHO laboratory manual for human semen testing and processing (5th edition), the sperm progressive motility is ≥ 32%.

    Baseline and 12 weeks

Secondary Outcomes (4)

  • Sperm concentration

    Baseline and 12 weeks

  • Sperm total motility

    Baseline and 12 weeks

  • Semen volume

    Baseline and 12 weeks

  • Sperm count

    Baseline and 12 weeks

Other Outcomes (3)

  • Testosterone

    Baseline and 12 weeks

  • Follicle stimulating hormone

    Baseline and 12 weeks

  • Luteinizing hormone

    Baseline and 12 weeks

Study Arms (2)

Exercise intervention group

EXPERIMENTAL

Participants will receive 12 weeks of moderate-intensity combined aerobic and resistance exercise training for 60 minutes three times per week on non-consecutive days (A total of 32 training sessions, excluding weekends, Labor Day, and the traditional Chinese Qingming Festival and the Dragon Boat Festival during that period). Aerobic exercises take the form of running and jumping rope. Resistance exercises involve different muscle groups in the upper and lower body.

Behavioral: Moderate-intensity combined aerobic and resistance exercise training

Control group

NO INTERVENTION

Participants maintain their original physical activity and lifestyle habits.

Interventions

Training sessions begin with a 10-minute warm-up period that includes jogging and dynamic muscle stretching. This is followed by 20 minutes of running/jumping rope on the playground. Each intervention participant will wear a heart rate armband (Polar OH1, Finland) for real-time heart rate detection to maintain achievement of a predetermined target heart rate and training intensity. Then, after 10 minutes of rest adjustment and preparation, a 20-minute resistance training session will be performed, including all major muscle groups. Resistance training will start at 50% of 1RM and increases intensity by 10% after every three sessions, with two sets of repetitions and 60-90 seconds of rest between sets. By the third week, it will reach 70% of 1RM, and repeat 3 sets at 70% of 1RM starting at week 4. After the end of week 6, re-evaluate the RM every 3 weeks and repeat 3 sets at 70% of the new 1RM (i.e., starting from Week 7 and Week 10), maintaining a 60-90 second rest between each sets.

Exercise intervention group

Eligibility Criteria

Age18 Years - 22 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • College student, 18 to 22 years old.
  • Good health with no eating disorders, mental health disorders, chronic diseases (such as diabetes and cardiovascular diseases), serious systemic illnesses, genitourinary diseases or infections.
  • Assessed as "low" physical activity trajectory on the self-reported International Physical Activity Questionnaire (IPAQ) over the past year.
  • In the past year, sperm progressive motility of less than 32% on at least two evaluations at three-month intervals.

You may not qualify if:

  • Smoking and alcohol dependence.
  • Use of drugs that affect sperm production function, such as hormones and antibiotics, in the past 3 months.
  • History of reproductive system surgery (e.g., cryptorchidism, postoperative varicocele).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Related Publications (1)

  • Hajizadeh Maleki B, Tartibian B, Chehrazi M. Effectiveness of Exercise Training on Male Factor Infertility: A Systematic Review and Network Meta-analysis. Sports Health. 2022 Jul-Aug;14(4):508-517. doi: 10.1177/19417381211055399. Epub 2021 Nov 20.

    PMID: 34806474BACKGROUND

Study Officials

  • Puyu Su, Professor

    Anhui Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 10, 2025

Study Start

March 10, 2025

Primary Completion

June 8, 2025

Study Completion

August 1, 2025

Last Updated

August 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

IPD will be only used in a peer-reviewed journal in order to protect the privacy of the study participants.

Locations