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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03553927
Other study ID # 18HH4412
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 16, 2018
Est. completion date December 31, 2022

Study information

Verified date April 2022
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Description:

Participants will receive dietary supplements or National Health Service (NHS) advice on healthy eating to achieve weight loss.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 136
Est. completion date December 31, 2022
Est. primary completion date August 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Low Energy Diet
Caloric restriction to achieve weight loss
Other:
NHS advice on healthy eating
Advice on energy requirements as per the British Dietetic Association

Locations

Country Name City State
United Kingdom Imperial College NHS Healthcare Trust North West London

Sponsors (1)

Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & 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, Lévy 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sperm concentration Sperm per ml 8 to 16 weeks
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