Actively Recruiting
The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males
Led by Third Affiliated Hospital of Zhengzhou University · Updated on 2026-04-13
98
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, aged 22 to 40 years
- Body mass index (BMI) of 30 kg/m8 or higher
- Willing and able to provide informed consent and attend all study visits at the Reproductive Center
- Spouse aged 20 to 40 years with regular menstrual cycles (21-35 days) and BMI between 18.5 and less than 25 kg/m8
- Planning assisted reproductive technology (ART) treatment at the study center due to male factor infertility
- Not participating in other research studies currently or in the past three months
- Willing to allow offspring conceived during the study to participate in follow-up research
You will not qualify if you...
- Active urinary or reproductive infections, hypogonadism, hyperprolactinemia, excessive estrogen, cryptorchidism, or other male reproductive system abnormalities
- Acute or chronic diseases affecting fertility, including systemic diseases, cytotoxic therapy history, or pelvic radiotherapy
- Digestive or metabolic disorders affecting absorption; history of eating disorders; allergies to meal replacement ingredients; gout, kidney stones, or gallstones; history of weight loss surgery
- Unhealthy lifestyle habits such as heavy alcohol use, daily smoking, drug abuse, or substance abuse
- Inability to fully consent, major mental disorders, jobs requiring intense physical exercise
- Current diets that conflict with study plans; use of hormones, anti-obesity drugs, or medications affecting hormones, carbohydrate metabolism, or appetite
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
Y
Yichun Guan, PhD
CONTACT
J
JingYi Han
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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