Investigating the Physiological Effects of Weight Loss on Male Fertility

Not Applicable

Completed

• Conditions: Obesity; Weight Loss; Male Infertility
• Interventions: Dietary Supplement: Low Energy Diet; Other: NHS advice on healthy eating

• Registration Number: NCT03553927
• Lead Sponsor: Imperial College London

Brief Summary

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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-16
• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-12
• Primary Completion: 2023-08-20
• Study Completion: 2023-09-18
• Results First Submitted: 2023-12-12
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Results First Posted: 2024-11-07
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 73

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]

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Energy Diet	Low Energy Diet	Commercially available diet products
NHS advice on healthy eating	NHS advice on healthy eating	Dietary / lifestyle advice programme

Primary Outcome Measures

Name	Time	Method
Sperm Concentration	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 Outcome Measures

Name	Time	Method
Reactive Oxygen Species (ROS)	16 weeks	ROS is measured by oxidative colour change of luminol per second per million sperm.
Morphology	16 weeks	the percentage of sperm that appear normal when semen is viewed under a microscope
Follicle Stimulating Hormone (FSH)	16 weeks	FSH produced in the pituitary gland, stimulates the testes to produce mature sperm.
Luteinizing Hormone (LH)	16 weeks	LH produced in the pituitary gland, stimulates the leydig cells in the testes to produce testosterone.
Total Motility	16 weeks	Total motility refers to the percentage of sperm making any sort of movement.
Progressive Motility	16 weeks	This type of motility refers to sperm that swim progressively, mostly in a straight line or large circles.
DNA Fragmentation Index (DFI)	16 weeks	Percentage of sperm with fragmented DNA
Testosterone	16 weeks	Testosterone is the primary androgen in men and is synthesized in the testes. It can be measured in the serum.
Sex Hormone-Binding Globulin (SHBG)	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.

Trial Locations

Locations (1)

Imperial College NHS Healthcare Trust; 🇬🇧 North West London, United Kingdom