N/A
Completed N=28
Investigating the Physiological Effects of Weight Loss on Male Fertility
Source: ClinicalTrials.gov NCT03553927 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Sperm Concentration — 53.6; 58.5; 20.1; 15 million sperms/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sperm Concentration |
53.6; 58.5; 20.1; 15 | — |
| SECONDARY Total Motility |
59.5; 60.8; 48.9; 45.4 | — |
| SECONDARY Progressive Motility |
53.3; 53.9; 42.8; 39.6 | — |
| SECONDARY DNA Fragmentation Index (DFI) |
7.7; 19.8; 18.4; 11.2 | — |
| SECONDARY Testosterone |
13.6; 12.4; 15.6; 13.7 | — |
| SECONDARY Sex Hormone-Binding Globulin (SHBG) |
30.2; 26.4; 24.2; 22.6 | — |
| SECONDARY Reactive Oxygen Species (ROS) |
13; 5 | — |
| SECONDARY Morphology |
1.2; 1.9; 0.6; 1.3 | — |
| SECONDARY Luteinizing Hormone (LH) |
3.3; 2.8; 3.5; 3.7 | — |
| SECONDARY Follicle Stimulating Hormone (FSH) |
3.8; 4.5; 5.4; 5 | — |
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
Data sourced from ClinicalTrials.gov (NCT03553927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.