Male InfertilityNCT03553927
Investigating the Physiological Effects of Weight Loss on Male Fertility
A study testing Low Energy Diet and NHS advice on healthy eating in people with Male Infertility and Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility, Obesity, Weight Loss
- What is being tested?
- Low Energy Diet and NHS advice on healthy eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 May 2018to 18 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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]
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College NHS Healthcare Trust
North West London, W12 0HS
About this study
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.
Read the detailed description
Participants will receive dietary supplements or National Health Service (NHS) advice on healthy eating to achieve weight loss.
- Conditions
- Male Infertility, Obesity, Weight Loss
- Being tested
- Low Energy Diet, NHS advice on healthy eating
- Keywords
- Male Infertility, Obesity
- Medical subject headings
- Infertility, Male, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Energy DietDietary supplement
Caloric restriction to achieve weight loss
NHS advice on healthy eatingOther
Advice on energy requirements as per the British Dietetic Association
| Study group | Role | What they receive |
|---|---|---|
| Low Energy Diet | Other | Commercially available diet products Receives: Dietary Supplement: Low Energy Diet |
| NHS advice on healthy eating | Other | Dietary / lifestyle advice programme Receives: Other: NHS advice on healthy eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm Concentration
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
Measured: 16 weeks
Secondary outcomes (9)
Total Motility
Total motility refers to the percentage of sperm making any sort of movement.
Measured: 16 weeks
Progressive Motility
This type of motility refers to sperm that swim progressively, mostly in a straight line or large circles.
Measured: 16 weeks
DNA Fragmentation Index (DFI)
Percentage of sperm with fragmented DNA
Measured: 16 weeks
Testosterone
Testosterone is the primary androgen in men and is synthesized in the testes. It can be measured in the serum.
Measured: 16 weeks
Sex Hormone-Binding Globulin (SHBG)
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.
Measured: 16 weeks
Reactive Oxygen Species (ROS)
ROS is measured by oxidative colour change of luminol per second per million sperm.
Measured: 16 weeks
Morphology
the percentage of sperm that appear normal when semen is viewed under a microscope
Measured: 16 weeks
Luteinizing Hormone (LH)
LH produced in the pituitary gland, stimulates the leydig cells in the testes to produce testosterone.
Measured: 16 weeks
Follicle Stimulating Hormone (FSH)
FSH produced in the pituitary gland, stimulates the testes to produce mature sperm.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start16 May 2018
- Primary completion20 Aug 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 sub-studies Study A (men with a normal sperm concentration) Study B (men with a low sperm concentration)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Channa Jayasena, MD PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553927
- Sponsor's protocol ID
- 18HH4412
- Status last verified
- Nov 2024
- First submitted
- 31 May 2018
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sermondade N, Faure C, Fezeu L, Shayeb AG, Bonde JP, Jensen TK, Van Wely M, Cao J, Martini AC, Eskandar M, Chavarro JE, Koloszar S, Twigt JM, Ramlau-Hansen CH, Borges E Jr, Lotti F, Steegers-Theunissen RP, Zorn B, Polotsky AJ, La Vignera S, Eskenazi B, Tremellen K, Magnusdottir EV, Fejes I, Hercberg S, Levy R, Czernichow S. BMI in relation to sperm count: an updated systematic review and collaborative meta-analysis. Hum Reprod Update. 2013 May-Jun;19(3):221-31. doi: 10.1093/humupd/dms050. Epub 2012 Dec 12.
PubMed 23242914
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Physiological Effects of Weight Loss on Male Fertility
- ClinicalTrials.gov ID
- NCT03553927
- Acronym / sponsor ID
- 18HH4412
- Conditions
- Male Infertility, Obesity, Weight Loss
- Keywords
- Male Infertility, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 16 May 2018 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 sub-studies Study A (men with a normal sperm concentration) Study B (men with a low sperm concentration)
| Arm | Type | Receives |
|---|---|---|
| Low Energy Diet | Other | Dietary Supplement: Low Energy DietCommercially available diet products |
| NHS advice on healthy eating | Other | Other: NHS advice on healthy eatingDietary / lifestyle advice programme |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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]
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Energy DietCaloric restriction to achieve weight loss | Dietary supplement | Low Energy Diet |
| NHS advice on healthy eatingAdvice on energy requirements as per the British Dietetic Association | Other | NHS advice on healthy eating |
Primary outcome
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
9 secondary outcomes
Total Motility
Time frame: 16 weeks
Progressive Motility
Time frame: 16 weeks
DNA Fragmentation Index (DFI)
Time frame: 16 weeks
Testosterone
Time frame: 16 weeks
Sex Hormone-Binding Globulin (SHBG)
Time frame: 16 weeks
Reactive Oxygen Species (ROS)
Time frame: 16 weeks
Morphology
Time frame: 16 weeks
Luteinizing Hormone (LH)
Time frame: 16 weeks
Follicle Stimulating Hormone (FSH)
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23242914Sermondade N, Faure C, Fezeu L, Shayeb AG, Bonde JP, Jensen TK, Van Wely M, Cao J, Martini AC, Eskandar M, Chavarro JE, Koloszar S, Twigt JM, Ramlau-Hansen CH, Borges E Jr, Lotti F, Steegers-Theunissen RP, Zorn B, Polotsky AJ, La Vignera S, Eskenazi B, Tremellen K, Magnusdottir EV, Fejes I, Hercberg S, Levy R, Czernichow S. BMI in relation to sperm count: an updated systematic review and collaborative meta-analysis. Hum Reprod Update. 2013 May-Jun;19(3):221-31. doi: 10.1093/humupd/dms050. Epub 2012 Dec 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Channa Jayasena, MD PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Energy Diet and NHS advice on healthy eating in people with Male Infertility and Obesity, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm Concentration (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.