Investigating the Physiological Effects of Weight Loss on Male Fertility
November 6, 2024 updated by: Imperial College London
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will receive dietary supplements or National Health Service (NHS) advice on healthy eating to achieve weight loss.
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
North West London, United Kingdom, W12 0HS
- Imperial College NHS Healthcare Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Low Energy Diet
Commercially available diet products
|
Caloric restriction to achieve weight loss
|
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Other: NHS advice on healthy eating
Dietary / lifestyle advice programme
|
Advice on energy requirements as per the British Dietetic Association
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Motility
Time Frame: 16 weeks
|
Total motility refers to the percentage of sperm making any sort of movement.
|
16 weeks
|
|
Progressive Motility
Time Frame: 16 weeks
|
This type of motility refers to sperm that swim progressively, mostly in a straight line or large circles.
|
16 weeks
|
|
DNA Fragmentation Index (DFI)
Time Frame: 16 weeks
|
Percentage of sperm with fragmented DNA
|
16 weeks
|
|
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.
|
16 weeks
|
|
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.
|
16 weeks
|
|
Reactive Oxygen Species (ROS)
Time Frame: 16 weeks
|
ROS is measured by oxidative colour change of luminol per second per million sperm.
|
16 weeks
|
|
Morphology
Time Frame: 16 weeks
|
the percentage of sperm that appear normal when semen is viewed under a microscope
|
16 weeks
|
|
Luteinizing Hormone (LH)
Time Frame: 16 weeks
|
LH produced in the pituitary gland, stimulates the leydig cells in the testes to produce testosterone.
|
16 weeks
|
|
Follicle Stimulating Hormone (FSH)
Time Frame: 16 weeks
|
FSH produced in the pituitary gland, stimulates the testes to produce mature sperm.
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Channa Jayasena, MD PhD, Imperial College London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2018
Primary Completion (Actual)
August 20, 2023
Study Completion (Actual)
September 18, 2023
Study Registration Dates
First Submitted
May 31, 2018
First Submitted That Met QC Criteria
May 31, 2018
First Posted (Actual)
June 12, 2018
Study Record Updates
Last Update Posted (Actual)
November 7, 2024
Last Update Submitted That Met QC Criteria
November 6, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18HH4412
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.