The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males
- Conditions
- IVF-ETObesityWeight LossMale FertilityArtificial Insemination
- Interventions
- Dietary Supplement: Low-carbohydrate diet groupBehavioral: Health Education Group
- Registration Number
- NCT06339840
- Lead Sponsor
- Third Affiliated Hospital of Zhengzhou University
- Brief Summary
Obesity, defined by WHO standards as having a body mass index (BMI) equal to or greater than 30 kg/m², affects approximately 800 million people worldwide. It is evident that obesity has become a serious public health issue, resulting in significant health burdens.
Previous systematic reviews have indicated an association between obesity and male factor infertility. In populations undergoing assisted reproductive technology (ART), some studies have shown a correlation between increased male BMI and adverse ART outcomes. Furthermore, the negative effects of obesity may also be transmitted to offspring through genetic and epigenetic changes in reproductive cell DNA, increasing their risk of obesity, metabolic diseases, or other chronic conditions.
Currently, there is a lack of data on the impact of weight loss in obese men on fertility, and it is unclear which nutritional pattern in lifestyle interventions can more effectively control weight, improve semen quality, and address related endocrine issues in obese men, thereby improving reproductive treatment outcomes.
Based on previous literature, we hypothesize that lifestyle interventions, particularly strict low-carbohydrate diets combined with lifestyle guidance, may offer greater health benefits for obese men. These benefits include effective weight loss, improvement in semen parameters, reproductive metabolic health, quality of life related to reproductive health, and the impact on reproductive treatment outcomes. This provides a basis for non-pharmacological intervention strategies and methods for the health of obese men.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 66
- Male, aged 22-40 years.
- BMI≥30 kg/m² (defined as obesity according to WHO standards).
- Patients who are willing and able to provide informed consent and follow all study procedures, including ongoing visits to the Reproductive Center of the Third Affiliated Hospital of Zhengzhou University and undergoing relevant tests
- Spouse aged 20-40 years, with menstrual regularity (menstrual cycle length of 21-35days, duration of 2-7days), with a BMI of 18.5≤BMI < 25 kg/m², planning for AIH or IVF treatment at our center due to male factor infertility.
- Not participating in any other research projects currently or in the preceding three months.
- Willing to allow offspring conceived through the study to participate in follow-up research.
- Male reproductive urinary system abnormalities: active urinary reproductive system infections; hypogonadism; hyperprolactinemia; excessive estrogen; cryptorchidism, etc.;
- Acute and chronic diseases that may affect fertility: chronic systemic diseases; history of systemic cytotoxic therapy or pelvic radiotherapy; other acute diseases that may affect study results;
- Digestive system and metabolic abnormalities: acute and chronic digestive system diseases affecting digestive absorption function; history of or current eating disorders; allergies to ingredients in meal replacement products; gout, kidney stones, or gallstones; history of weight loss surgery;
- Unhealthy lifestyle habits: meeting at least one of the following conditions: heavy alcohol consumption, daily smoking, history of drug abuse, history of substance abuse;
- Personal factors affecting trial participation: impaired capacity to fully consent to participation in the study; major mental disorders; occupations requiring intense physical exercise; current diets that may interfere with the dietary plans of this study; exclusion of current or past use of hormones or anti-obesity drugs, or the use of other medications that affect hormone levels, carbohydrate metabolism, or appetite.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-carbohydrate diet group Low-carbohydrate diet group During the 12-week intervention, the first 8 weeks constitute the weight loss phase, where a low-carbohydrate diet, combined with meal replacement and daily dietary intake, is employed. Lifestyle guidance is provided on a one-to-one basis, accompanied by monitoring through a mobile platform. The subsequent 4 weeks involve the transition phase, during which personalized dietary and lifestyle adjustments are made Health Education Group Health Education Group 12 weeks of one-on-one health promotion and mobile platform monitoring
- Primary Outcome Measures
Name Time Method Weight Regular data collection between baseline and 12 weeks of weight loss intervention kilogram (kg)
- Secondary Outcome Measures
Name Time Method Visceral fat Collected at baseline and until 12 weeks after weight loss intervention (g), Assessed by an Anthropometric Analyzer
Semen parameter- Sperm concentration Collected at baseline and until 12 weeks after weight loss intervention Concentration (in million sperm cells/ml)
Semen parameter- Sperm motility Collected at baseline and until 12 weeks after weight loss intervention Sperm motility (%)
Semen parameter- Sperm progressive motility (PR) Collected at baseline and until 12 weeks after weight loss intervention PR(%)
Waist circumference Regular data collection between baseline and 12 weeks of weight loss intervention Centimetre(cm)
Semen parameter- Sperm morphology Collected at baseline and until 12 weeks after weight loss intervention Morphology (%)
Semen parameter- Sperm DNA fragmentation index (DFI) Collected at baseline and until 12 weeks after weight loss intervention DFI (%)
Glucose metabolism-fasting glucose Collected at baseline and until 12 weeks after weight loss intervention Glucose metabolism-OGTT Collected at baseline and until 12 weeks after weight loss intervention Oral Glucose Tolerance Test
Glucose metabolism-HbA1c Collected at baseline and until 12 weeks after weight loss intervention Semen parameter- Non-progressive motility (NP) Collected at baseline and until 12 weeks after weight loss intervention NP(%)
Heart rate Regular data collection between baseline and 12 weeks of weight loss intervention beats per minute
Glucose metabolism-C-peptide Collected at baseline and until 12 weeks after weight loss intervention Semen parameter- Immotility (IM) Collected at baseline and until 12 weeks after weight loss intervention IM(%)
body mass index (BMI) Regular data collection between baseline and 12 weeks of weight loss intervention Calculated ad weight (kg)/height(m)\^2
Hip circumference Regular data collection between baseline and 12 weeks of weight loss intervention Centimetre(cm)
Lean mass Collected at baseline and until 12 weeks after weight loss intervention (g), Assessed by an Anthropometric Analyzer
Fat mass Collected at baseline and until 12 weeks after weight loss intervention (g), Assessed by an Anthropometric Analyzer
Abdominal fat Collected at baseline and until 12 weeks after weight loss intervention (g), Assessed by an Anthropometric Analyzer
Blood pressure Regular data collection between baseline and 12 weeks of weight loss intervention mmHg
Lipid profile-total cholesterol Collected at baseline and until 12 weeks after weight loss intervention Glucose metabolism-insulin Collected at baseline and until 12 weeks after weight loss intervention Sex hormones Collected at baseline and until 12 weeks after weight loss intervention Samples will be analyzed for total testosterone, free testosterone, luteinizing hormone(LH), follicle-stimulating hormone(FSH), pituitary prolactin(PRL) and anti-müllerian hormone(AMH)
Lipid profile-triglycerides Collected at baseline and until 12 weeks after weight loss intervention Lipid profile-LDL Collected at baseline and until 12 weeks after weight loss intervention low-density lipoprotein
Lipid profile-HDL Collected at baseline and until 12 weeks after weight loss intervention high-density lipoprotein
Lipid profile-VLDL Collected at baseline and until 12 weeks after weight loss intervention very-low-density lipoprotein
Trial Locations
- Locations (1)
Third Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China