Investigating the Physiological Effects of Weight Loss on Male Fertility

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-16

Study Completion Date

2023-09-18

Brief Summary

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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.

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Detailed Description

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

Conditions

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Male Infertility Obesity Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 sub-studies Study A (men with a normal sperm concentration) Study B (men with a low sperm concentration)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low Energy Diet

Commercially available diet products

Group Type OTHER

Low Energy Diet

Intervention Type DIETARY_SUPPLEMENT

Caloric restriction to achieve weight loss

NHS advice on healthy eating

Dietary / lifestyle advice programme

Group Type OTHER

NHS advice on healthy eating

Intervention Type OTHER

Advice on energy requirements as per the British Dietetic Association

Interventions

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Low Energy Diet

Caloric restriction to achieve weight loss

Intervention Type DIETARY_SUPPLEMENT

NHS advice on healthy eating

Advice on energy requirements as per the British Dietetic Association

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes