Clinical trial NCT06339840: The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males
Official title: The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Weight Loss
Male Fertility
Artificial Insemination
IVF-ET
Lead sponsor: Third Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 66
Sex: MALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. Male, aged 22-40 years.
2. BMI≥30 kg/m² (defined as obesity according to WHO standards).
3. 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
4. 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 \&lt; 25 kg/m², planning for AIH or IVF treatment at our center due to male factor infertility.
5. Not participating in any other research projects currently or in the preceding three months.
6. Willing to allow offspring conceived through the study to participate in follow-up research.

Exclusion Criteria:

1. Male reproductive urinary system abnormalities: active urinary reproductive system infections; hypogonadism; hyperprolactinemia; excessive estrogen; cryptorchidism, etc.;
2. 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;
3. 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;
4. Unhealthy lifestyle habits: meeting at least one of the following conditions: heavy alcohol consumption, daily smoking, history of drug abuse, history of substance abuse;
5. 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.

Primary outcomes:
measure: Weight
timeFrame: Regular data collection between baseline and 12 weeks of weight loss intervention
Secondary outcomes:
measure: Semen parameter- Sperm concentration
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Semen parameter- Sperm motility
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Semen parameter- Sperm morphology
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Semen parameter- Sperm DNA fragmentation index (DFI)
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Semen parameter- Sperm progressive motility (PR)
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Semen parameter- Non-progressive motility (NP)
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Semen parameter- Immotility (IM)
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: body mass index (BMI)
timeFrame: Regular data collection between baseline and 12 weeks of weight loss intervention
measure: Waist circumference
timeFrame: Regular data collection between baseline and 12 weeks of weight loss intervention
measure: Hip circumference
timeFrame: Regular data collection between baseline and 12 weeks of weight loss intervention
measure: Lean mass
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Fat mass
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Abdominal fat
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Visceral fat
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Blood pressure
timeFrame: Regular data collection between baseline and 12 weeks of weight loss intervention
measure: Heart rate
timeFrame: Regular data collection between baseline and 12 weeks of weight loss intervention
measure: Lipid profile-triglycerides
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Lipid profile-LDL
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Lipid profile-HDL
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Lipid profile-VLDL
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Lipid profile-total cholesterol
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Glucose metabolism-fasting glucose
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Glucose metabolism-OGTT
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Glucose metabolism-insulin
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Glucose metabolism-C-peptide
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Glucose metabolism-HbA1c
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Sex hormones
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
Other outcomes:
measure: Adult background
timeFrame: Collected prior baseline
measure: Questionnaire - Adult physical activity
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Questionnaire - Quality of life
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Questionnaire - Psychological condition
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Questionnaire - Sleep
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Spouse's reproductive outcome - Methods of Fertilization
timeFrame: through study completion, an average of 6 months
measure: Spouse's reproductive outcome - Time to pregnancy
timeFrame: through study completion, an average of 6 months
measure: Spouse's reproductive outcome - Length of gestational age
timeFrame: Assessed at birth of offspring
measure: Spouse's reproductive outcome - Medication use
timeFrame: Collected from initiation of labor until completed birth of offspring
measure: Spouse's reproductive outcome - Delivery mode
timeFrame: Collected at birth of offspring
measure: Spouse's reproductive outcome - Pregnancy complications
timeFrame: through study completion, an average of 18 months
measure: Spouse's reproductive outcome - Obstetrics complications
timeFrame: Collected at birth of offspring
measure: Fetal and offspring - Apgar score
timeFrame: Collected at birth of offspring
measure: Fetal and offspring - body weight
timeFrame: through study completion, an average of 18 months
measure: Fetal and offspring - Neonatal fat mass
timeFrame: Assessed at birth (strived <24 hours, but allow <48 hours)
measure: Fetal and offspring - Birth defects/abnormalities
timeFrame: Collected at birth of offspring
measure: Fetal and offspring - length
timeFrame: through study completion, an average of 18 months
measure: Fetal and offspring - abdominal circumference
timeFrame: through study completion, an average of 18 months
measure: Fetal and offspring - crown circumference
timeFrame: through study completion, an average of 18 months
measure: Fetal and offspring - Glucose metabolism
timeFrame: Collected at 6, 12 and 18 months after birth
measure: Fetal and offspring - Lipid profile
timeFrame: Collected at 6, 12 and 18 months after birth
measure: Fetal and offspring - Offspring growth factors and hormones
timeFrame: Collected at 6, 12 and 18 months after birth
measure: Fetal and offspring - Cognitive development of offspring
timeFrame: Collected at 6, 12 and 18 months after birth.
measure: Labs - Semen epigenetics marks
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Labs - Adult Epigenetics
timeFrame: Collected at baseline and until 12 weeks after weight loss intervention
measure: Labs - Cord blood - epigenetics
timeFrame: Collected at birth
measure: Labs - Cord tissue
timeFrame: Collected at birth
measure: Labs - Placenta
timeFrame: Collected at birth
measure: Labs - Placenta - biopsies
timeFrame: Collected at birth
measure: Labs - Offspring urine
timeFrame: Collected at birth and at 1, 3, 6, 12 and 18 months of age
measure: Labs - Offspring feces
timeFrame: Collected at birth and at 1, 3, 6, 12 and 18 months of age
Locations:
city: Zhengzhou
country: China
facility: Third Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References: