Lifestyle changes to improve weight and fertility in obese men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Third Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Yichun Guan, PhD
• Email: lisamayguan@163.com
• Phone: +8613608695579

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.