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Investigating the Physiological Effects of Weight Loss on Male Fertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553927
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Male Infertility Obesity Weight Loss Dietary Supplement: Low Energy Diet Other: NHS advice on healthy eating Not Applicable

Detailed Description:
Participants will receive dietary supplements or NHS advice on healthy eating to achieve weight loss.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigating the Physiological Effects of Weight Loss on Male Fertility
Actual Study Start Date : May 16, 2018
Estimated Primary Completion Date : August 20, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Low Energy Diet
Commercially available diet products
Dietary Supplement: Low Energy Diet
Caloric restriction to achieve weight loss

NHS advice on healthy eating
Dietary / lifestyle advice programme
Other: NHS advice on healthy eating
Advice on energy requirements as per the British Dietetic Association




Primary Outcome Measures :
  1. Sperm concentration [ Time Frame: 8 to 20 weeks ]
    Sperm per ml



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) >25 kg/m^2
  • Evidence of reduced reproductive capacity (e.g. reduced sperm concentration or motility)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553927


Contacts
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Contact: Channa N Jayasena, MD PhD 0208 8383 3242 c.jayasena@imperial.ac.uk

Locations
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United Kingdom
Imperial College NHS Healthcare Trust Recruiting
North West London, United Kingdom, W12 0HS
Contact: Channa Jayasena, MA PhD MRCP    020 8383 3242    c.jayasena@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Channa Jayasena, MD PhD Imperial College London
  Study Documents (Full-Text)

Documents provided by Imperial College London:

Publications:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03553927    
Other Study ID Numbers: 18HH4412
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Male Infertility
Obesity
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes
Genital Diseases, Male
Genital Diseases, Female