Clinical trial NCT03553927: 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
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Obesity
Weight Loss
Keywords: Male Infertility
Obesity
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 73
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 sub-studies Study A (men with a normal sperm concentration) Study B (men with a low sperm concentration)
Primary purpose: TREATMENT

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.

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 \[applicable for study B\]

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

Primary outcomes:
measure: Sperm Concentration
timeFrame: 16 weeks
Secondary outcomes:
measure: Total Motility
timeFrame: 16 weeks
measure: Progressive Motility
timeFrame: 16 weeks
measure: DNA Fragmentation Index (DFI)
timeFrame: 16 weeks
measure: Testosterone
timeFrame: 16 weeks
measure: Sex Hormone-Binding Globulin (SHBG)
timeFrame: 16 weeks
measure: Reactive Oxygen Species (ROS)
timeFrame: 16 weeks
measure: Morphology
timeFrame: 16 weeks
measure: Luteinizing Hormone (LH)
timeFrame: 16 weeks
measure: Follicle Stimulating Hormone (FSH)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: North West London
country: United Kingdom
facility: Imperial College NHS Healthcare Trust
Study officials:
affiliation: Imperial College London
name: Channa Jayasena, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.