NCT03553927

Investigating the Physiological Effects of Weight Loss on Male Fertility

Completed NA Results posted Last updated 7 November 2024

What this trial tests

NA trial testing Low Energy Diet in Male Infertility in 73 participants. Completed in 18 September 2023.

Timeline

16 May 2018

Primary endpoint
20 August 2023

18 September 2023

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	73
Start date	16 May 2018
Primary completion	20 August 2023
Estimated completion	18 September 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Low Energy Diet
• NHS advice on healthy eating

Conditions studied

• Male Infertility — all drugs for Male Infertility →
• Obesity — all drugs for Obesity →
• Weight Loss — all drugs for Weight Loss →

Sponsor

Imperial College London

Who can join

Adults 18 to 60, male only, with Male Infertility or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sperm Concentration Primary · 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

Study A (men with normal sperm concentration)

Group	Value	95% CI
Low Energy Diet	53.6	± 36.4
NHS Advice on Healthy Eating	58.5	± 32.8

Study B (men with low sperm concentration)

Group	Value	95% CI
Low Energy Diet	20.1	± 59.16
NHS Advice on Healthy Eating	15	± 16.8

Total Motility Secondary · 16 weeks

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

men with a normal sperm concentration

Group	Value	95% CI
Low Energy Diet	59.5	± 9.6
NHS Advice on Healthy Eating	60.8	± 6.3

men with a low sperm concentration

Group	Value	95% CI
Low Energy Diet	48.9	± 12
NHS Advice on Healthy Eating	45.4	± 16.1

Progressive Motility Secondary · 16 weeks

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

Study A (men with a normal sperm concentration)

Group	Value	95% CI
Low Energy Diet	53.3	± 10.4
NHS Advice on Healthy Eating	53.9	± 6.1

study B (men with a low sperm concentration)

Group	Value	95% CI
Low Energy Diet	42.8	± 14.1
NHS Advice on Healthy Eating	39.6	± 17

DNA Fragmentation Index (DFI) Secondary · 16 weeks

Percentage of sperm with fragmented DNA

Study A (men with a normal sperm concentration)

Group	Value	95% CI
Low Energy Diet	7.7	± 8.7
NHS Advice on Healthy Eating	19.8	± 9.6

study B (men with a low sperm concentration)

Group	Value	95% CI
Low Energy Diet	18.4	± 11.7
NHS Advice on Healthy Eating	11.2	± 11

Testosterone Secondary · 16 weeks

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

Study A (men with a normal sperm concentration)

Group	Value	95% CI
Low Energy Diet, Men With Normal Sperm Concentration	13.6	± 5
NHS Advice on Healthy Eating, Men With Normal Sperm Concentration	12.4	± 2.8

study B (men with a low sperm concentration)

Group	Value	95% CI
Low Energy Diet, Men With Normal Sperm Concentration	15.6	± 6.2
NHS Advice on Healthy Eating, Men With Normal Sperm Concentration	13.7	± 4.1

Sex Hormone-Binding Globulin (SHBG) Secondary · 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.

(men with a normal sperm concentration)

Group	Value	95% CI
Low Energy Diet	30.2	± 12.6
NHS Advice on Healthy Eating	26.4	± 7

study B (men with a low sperm concentration)

Group	Value	95% CI
Low Energy Diet	24.2	± 12.4
NHS Advice on Healthy Eating	22.6	± 8.1

Reactive Oxygen Species (ROS) Secondary · 16 weeks

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

Group	Value	95% CI
Low Energy Diet	13	3 – 39.1
NHS Advice on Healthy Eating	5	0.9 – 37.4

Morphology Secondary · 16 weeks

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

Study A (men with a normal sperm concentration)

Group	Value	95% CI
Low Energy Diet	1.2	± 1.1
NHS Advice on Healthy Eating	1.9	± 1.7

Study B (men with a low sperm concentration)

Group	Value	95% CI
Low Energy Diet	0.6	± 0.6
NHS Advice on Healthy Eating	1.3	± 1.7

Luteinizing Hormone (LH) Secondary · 16 weeks

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

Study A (men with a normal sperm concentration)

Group	Value	95% CI
Low Energy Diet	3.3	± 1.4
NHS Advice on Healthy Eating	2.8	± 1.2

Study B (men with a low sperm concentration)

Group	Value	95% CI
Low Energy Diet	3.5	± 1.4
NHS Advice on Healthy Eating	3.7	± 1.5

Follicle Stimulating Hormone (FSH) Secondary · 16 weeks

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

Study A (men with a normal sperm concentration)

Group	Value	95% CI
Low Energy Diet	3.8	± 2.1
NHS Advice on Healthy Eating	4.5	± 2.2

Study B (men with a low sperm concentration)

Group	Value	95% CI
Low Energy Diet	5.4	± 2.6
NHS Advice on Healthy Eating	5	± 2.4

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Preconception lifestyle advice for people with infertility.
   Boedt T, Vanhove AC, Vercoe MA, Matthys C, et al · · 2021 · cited 31× · PMID 33914901 · DOI 10.1002/14651858.cd008189.pub3