Skip to main content
OpenTrials
Completed

NCT Number: NCT03553927

Investigating the Physiological Effects of Weight Loss on Male Fertility

The purpose of this study is to determine the physiological effects of weight loss on seminal parameters in male participants with reduced reproductive capacity. Learning more about the physiological role of weight loss on reproductive function and metabolic profile of overweight and obese men may give us a better understanding of male fertility and improve the management of patients with reduced fertility. The effects of weight loss on seminal quality are not well understood.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Male Infertility Body Weight Body Weight Changes Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Weight Loss

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College NHS Healthcare Trust

North West London, W12 0HS, United Kingdom

About this study

Participants will receive dietary supplements or National Health Service (NHS) advice on healthy eating to achieve weight loss.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) ≥ 30 kg/m^2 [Part: 1, 2& 3]
  • Evidence of reduced reproductive capacity (e.g. reduced sperm concentration [applicable for study B]

Exclusion criteria

  • History of undescended testes, testicular surgery or mumps infection
  • Hormonal therapy such as testosterone or selective oestrogen receptor modulators
  • History of systemic cytotoxic therapy or pelvic radiotherapy
  • Chronic systemic disease, such as cardiac, renal or liver failure
  • At least one of the following:

Alcohol intake >30 units per week Smoking daily Recreational drug use at a frequency not less than weekly

  • Acute illness likely to affect the result of study
  • Impaired ability to provide full consent to take part in the study
  • An occupation requiring strenuous physical exercise that may require a high energy diet

Treatment and study plan

Low Energy Diet

Dietary Supplement

Caloric restriction to achieve weight loss

NHS advice on healthy eating

Other

Advice on energy requirements as per the British Dietetic Association

Primary outcomes

  1. Sperm Concentration

    Time frame: 16 weeks

    The number of sperm per millimeter of semen. Sperm concentration is an important factor affecting male fertility. It is calculated on a standard semen analysis

Secondary outcomes

  1. Total Motility

    Time frame: 16 weeks

    Total motility refers to the percentage of sperm making any sort of movement.

  2. Progressive Motility

    Time frame: 16 weeks

    This type of motility refers to sperm that swim progressively, mostly in a straight line or large circles.

  3. DNA Fragmentation Index (DFI)

    Time frame: 16 weeks

    Percentage of sperm with fragmented DNA

  4. Testosterone

    Time frame: 16 weeks

    Testosterone is the primary androgen in men and is synthesized in the testes. It can be measured in the serum.

  5. Sex Hormone-Binding Globulin (SHBG)

    Time frame: 16 weeks

    SHBG is a protein that is produced by the liver and binds tightly to the hormones testosterone, dihydrotestosterone (DHT) and oestradiol, and transports them in the blood in an inactive form.

  6. Reactive Oxygen Species (ROS)

    Time frame: 16 weeks

    ROS is measured by oxidative colour change of luminol per second per million sperm.

  7. Morphology

    Time frame: 16 weeks

    the percentage of sperm that appear normal when semen is viewed under a microscope

  8. Luteinizing Hormone (LH)

    Time frame: 16 weeks

    LH produced in the pituitary gland, stimulates the leydig cells in the testes to produce testosterone.

  9. Follicle Stimulating Hormone (FSH)

    Time frame: 16 weeks

    FSH produced in the pituitary gland, stimulates the testes to produce mature sperm.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2018
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.