Investigating the Physiological Effects of Weight Loss on Male Fertility

NCT03553927 | Completed Results DMC

• 1 other identifier: 18HH4412
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility; Obesity; Weight Loss

Keywords

Male Infertility; Obesity

Outcome Measures

Primary Outcomes (1)

• 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

  16 weeks

Secondary Outcomes (9)

• Total Motility

  16 weeks

• Progressive Motility

  16 weeks

• DNA Fragmentation Index (DFI)

  16 weeks

• Testosterone

  16 weeks

• Sex Hormone-Binding Globulin (SHBG)

  16 weeks

Study Arms (2)

Low Energy Diet

OTHER

Commercially available diet products

Dietary Supplement: Low Energy Diet

NHS advice on healthy eating

OTHER

Dietary / lifestyle advice programme

Other: NHS advice on healthy eating

Interventions

Low Energy Diet DIETARY_SUPPLEMENT

Caloric restriction to achieve weight loss

Low Energy Diet

NHS advice on healthy eating OTHER

Advice on energy requirements as per the British Dietetic Association

NHS advice on healthy eating

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) ≥ 30 kg/m\^2 \[Part: 1, 2\& 3\]
• Evidence of reduced reproductive capacity (e.g. reduced sperm concentration \[applicable for study B\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College NHS Healthcare Trust

North West London, W12 0HS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23242914 BACKGROUND

MeSH Terms

Conditions

Infertility, Male; Obesity; Weight Loss

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Channa Jayasena
• Organization: Imperial College London

c.jayasena@imperial.ac.uk

02083833242

Study Officials

• Channa Jayasena, MD PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 12, 2018
• Study Start: May 16, 2018
• Primary Completion: August 20, 2023
• Study Completion: September 18, 2023
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)