Back to resultsInvestigating the Physiological Effects of Weight Loss on Male Fertility
Primary Purpose
Male Infertility, Obesity, Weight Loss
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Low Energy Diet
NHS advice on healthy eating
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility focused on measuring Male Infertility, Obesity
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) ≥ 30 kg/m^2 [Part: 1, 2& 3]
- Evidence of reduced reproductive capacity (e.g. reduced sperm concentration or motility) [Part 3 only]
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
Sites / Locations
- Imperial College NHS Healthcare Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Low Energy Diet
NHS advice on healthy eating
Arm Description
Commercially available diet products
Dietary / lifestyle advice programme
Outcomes
Primary Outcome Measures
Sperm concentration
Sperm per ml
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03553927
Brief Title
Investigating the Physiological Effects of Weight Loss on Male Fertility
Official Title
Investigating the Physiological Effects of Weight Loss on Male Fertility
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 16, 2018 (Actual)
Primary Completion Date
August 20, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility, Obesity, Weight Loss
Keywords
Male Infertility, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Energy Diet
Arm Type
Other
Arm Description
Commercially available diet products
Arm Title
NHS advice on healthy eating
Arm Type
Other
Arm Description
Dietary / lifestyle advice programme
Intervention Type
Dietary Supplement
Intervention Name(s)
Low Energy Diet
Intervention Description
Caloric restriction to achieve weight loss
Intervention Type
Other
Intervention Name(s)
NHS advice on healthy eating
Intervention Description
Advice on energy requirements as per the British Dietetic Association
Primary Outcome Measure Information:
Title
Sperm concentration
Description
Sperm per ml
Time Frame
8 to 16 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) ≥ 30 kg/m^2 [Part: 1, 2& 3]
Evidence of reduced reproductive capacity (e.g. reduced sperm concentration or motility) [Part 3 only]
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Channa Jayasena, MD PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College NHS Healthcare Trust
City
North West London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23242914
Citation
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.
Results Reference
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Investigating the Physiological Effects of Weight Loss on Male Fertility
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