Lifestyle changes to improve weight and fertility in obese men
The Impact of Lifestyle Intervention on Weight and Fertility in Obese Males
This study is testing whether a low-carb diet and health education can help obese men aged 22-40 lose weight and improve their fertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 22 Years to 40 Years |
| Sex | Male |
| Sponsor | Third Affiliated Hospital of Zhengzhou University Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06339840 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of lifestyle interventions, specifically a low-carbohydrate diet and health education, on weight loss and fertility outcomes in obese males. It targets men aged 22-40 with a BMI of 30 kg/m² or higher, exploring how weight loss can improve semen quality and fertility, particularly in the context of assisted reproductive technology. The study aims to fill the gap in data regarding the relationship between obesity and male fertility, as well as the potential benefits of dietary changes.
Who should consider this trial
Good fit: Ideal candidates are obese males aged 22-40 who are planning for artificial insemination or IVF treatment due to male factor infertility.
Not a fit: Patients with male reproductive urinary system abnormalities or acute and chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fertility outcomes for obese men seeking assisted reproductive technologies.
How similar studies have performed: While there is limited data on this specific approach, previous studies have indicated a correlation between obesity and male infertility, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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 ART 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.
Where this trial is running
Zhengzhou, Henan
- Third Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Yichun Guan, PhD
- Email: lisamayguan@163.com
- Phone: +8613608695579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.