Investigating the Physiological Effects of Weight Loss on Male Fertility

Obesity Clinical Trial

Official title:

Investigating the Physiological Effects of Weight Loss on Male Fertility

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03553927
• Other study ID #: 18HH4412
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Body Weight
• Infertility
• Infertility, Male
• Male Infertility
• Obesity
• Weight Loss

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