The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males

Launched by THIRD AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY · Mar 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how changes in lifestyle, particularly diet and exercise, can help obese men improve their weight and fertility. Obesity, defined as having a body mass index (BMI) of 30 or more, can negatively affect male fertility and reproductive health. The researchers believe that following a strict low-carbohydrate diet along with lifestyle guidance may lead to better weight loss, improved semen quality, and overall reproductive health for these men, which could also enhance their partners' chances of successful pregnancy through treatments like artificial insemination or IVF.

To participate in this trial, men must be between 22 and 40 years old, have a BMI of 30 or higher, and be willing to commit to regular visits and testing at the study center. They should also have a partner who is planning to conceive and meets specific health criteria. Participants can expect to follow a new dietary plan, receive support for lifestyle changes, and contribute to important research that could help future couples facing fertility challenges. If you're considering joining, it's important to know that certain health conditions and lifestyle habits may exclude you from participating.

Gender

MALE

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 \< 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.