protocolSection identificationModule nctId: NCT06339840, orgStudyIdInfo id: 2024-036-01, briefTitle: The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Third Affiliated Hospital of Zhengzhou University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Obesity, conditions: Weight Loss, conditions: Male Fertility, conditions: Artificial Insemination, conditions: IVF-ET, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Based on the design of this clinical trial, blinding is not implement ed for participants and care providers. Blinding is only applied to outcome assessors and investigators. Outcome assessors are clinical staff members who are unaware of the group assignments, and data is collected directly from the medical records system by EDC data entry personnel for management (double-checking). Data analysts will directly extract information and data from the EDC database for statistical analysis. Blinding will be revealed upon completion of result analysis., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Low-carbohydrate diet group, interventions name: Health Education Group, outcomesModule primaryOutcomes measure: Weight, secondaryOutcomes measure: Semen parameter- Sperm concentration, secondaryOutcomes measure: Semen parameter- Sperm motility, secondaryOutcomes measure: Semen parameter- Sperm morphology, secondaryOutcomes measure: Semen parameter- Sperm DNA fragmentation index (DFI), secondaryOutcomes measure: Semen parameter- Sperm progressive motility (PR), secondaryOutcomes measure: Semen parameter- Non-progressive motility (NP), secondaryOutcomes measure: Semen parameter- Immotility (IM), secondaryOutcomes measure: body mass index (BMI), secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Hip circumference, secondaryOutcomes measure: Lean mass, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Abdominal fat, secondaryOutcomes measure: Visceral fat, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Lipid profile-triglycerides, secondaryOutcomes measure: Lipid profile-LDL, secondaryOutcomes measure: Lipid profile-HDL, secondaryOutcomes measure: Lipid profile-VLDL, secondaryOutcomes measure: Lipid profile-total cholesterol, secondaryOutcomes measure: Glucose metabolism-fasting glucose, secondaryOutcomes measure: Glucose metabolism-OGTT, secondaryOutcomes measure: Glucose metabolism-insulin, secondaryOutcomes measure: Glucose metabolism-C-peptide, secondaryOutcomes measure: Glucose metabolism-HbA1c, secondaryOutcomes measure: Sex hormones, otherOutcomes measure: Adult background, otherOutcomes measure: Questionnaire - Adult physical activity, otherOutcomes measure: Questionnaire - Quality of life, otherOutcomes measure: Questionnaire - Psychological condition, otherOutcomes measure: Questionnaire - Sleep, otherOutcomes measure: Spouse's reproductive outcome - Methods of Fertilization, otherOutcomes measure: Spouse's reproductive outcome - Time to pregnancy, otherOutcomes measure: Spouse's reproductive outcome - Length of gestational age, otherOutcomes measure: Spouse's reproductive outcome - Medication use, otherOutcomes measure: Spouse's reproductive outcome - Delivery mode, otherOutcomes measure: Spouse's reproductive outcome - Pregnancy complications, otherOutcomes measure: Spouse's reproductive outcome - Obstetrics complications, otherOutcomes measure: Fetal and offspring - Apgar score, otherOutcomes measure: Fetal and offspring - body weight, otherOutcomes measure: Fetal and offspring - Neonatal fat mass, otherOutcomes measure: Fetal and offspring - Birth defects/abnormalities, otherOutcomes measure: Fetal and offspring - length, otherOutcomes measure: Fetal and offspring - abdominal circumference, otherOutcomes measure: Fetal and offspring - crown circumference, otherOutcomes measure: Fetal and offspring - Glucose metabolism, otherOutcomes measure: Fetal and offspring - Lipid profile, otherOutcomes measure: Fetal and offspring - Offspring growth factors and hormones, otherOutcomes measure: Fetal and offspring - Cognitive development of offspring, otherOutcomes measure: Labs - Semen epigenetics marks, otherOutcomes measure: Labs - Adult Epigenetics, otherOutcomes measure: Labs - Cord blood - epigenetics, otherOutcomes measure: Labs - Cord tissue, otherOutcomes measure: Labs - Placenta, otherOutcomes measure: Labs - Placenta - biopsies, otherOutcomes measure: Labs - Offspring urine, otherOutcomes measure: Labs - Offspring feces, eligibilityModule sex: MALE, minimumAge: 22 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False