Status:
NOT_YET_RECRUITING
Can Fat-Burning Shots Boost Fertility? Comparing Weight-Loss Injections vs. Healthy Habits for Obese Men With Low Sperm Health
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Obesity-related Male Infertility
Eligibility:
MALE
20-45 years
Phase:
PHASE2
Brief Summary
Why is this study being done? Obesity can harm men's fertility by lowering sperm quality and hormone levels, making it harder to have children. Weight loss through diet and exercise helps, but it's of...
Eligibility Criteria
Inclusion
- (1) Married men aged 20-45 (considering childbearing age and ensuring fertility requirements), with female spouses \<40 years old and no significant infertility factors.
- (2) Meeting China's adult obesity criteria: BMI ≥28 kg/m² or meeting central obesity criteria (waist circumference ≥90 cm).
- (3) Meeting WHO diagnostic criteria for male infertility: Failure to achieve pregnancy after ≥1 year of unprotected normal sexual activity, diagnosed as male-factor infertility after basic evaluation (e.g., oligospermia, asthenospermia, or high sperm deformity rate; excluding azoospermia), with essentially normal fertility function in the female spouse.
- (4) Abnormal semen analysis: Baseline semen testing shows low sperm concentration or motility (e.g., sperm concentration \<15×10⁶/mL or progressive motility \<32%).
- (5) Willing to undergo randomization and corresponding interventions, able to attend regular follow-ups, and provide semen and blood samples.
- (6) Informed consent to participate in the study and signing of the informed consent form.
Exclusion
- (1) Other clear causes affecting male fertility: e.g., obstructive azoospermia, severe oligospermia (sperm concentration \<5×10⁶/mL), history of bilateral cryptorchidism surgery, genetic abnormalities (chromosomal anomalies such as Klinefelter syndrome, Y-chromosome microdeletions), severe reproductive tract damage, or infection history.
- (2) Spouse has significant infertility factors (e.g., bilateral tubal blockage, severe ovulation disorders) without effective treatment, which may severely impact pregnancy outcomes.
- (3) Previous bariatric surgery (e.g., gastric bypass, sleeve gastrectomy) or current use of other weight-loss medications (e.g., orlistat), or weight fluctuation \>5% within 3 months before enrollment.
- (4) Endocrine diseases affecting reproduction or sexual function: e.g., uncontrolled diabetes (HbA1c \>9%) or insulin-treated diabetes, clinically significant thyroid dysfunction, hyperprolactinemia.
- (5) Severe systemic diseases: Including significant cardiovascular diseases (unstable angina, class III-IV heart failure, etc.), active liver disease (transaminases \>2× upper limit of normal), severe renal impairment (eGFR \<30 mL/min/1.73m²), etc., making participation in clinical trials inappropriate.
- (6) History of acute pancreatitis; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2) (GLP-1RA is contraindicated in these cases)
- ; or conditions unsuitable for weight-loss medications, such as severe hepatic/renal impairment or gallstones.
- (7) Use of GLP-1 receptor agonist therapy within the past 6 months. (8) Received other fertility-improving treatments within the past 6 months that cannot be discontinued (e.g., gonadotropins, clomiphene, testosterone preparations, or other drugs affecting semen such as exogenous testosterone or 5-alpha-reductase inhibitors).
- (9) Alcohol or drug abuse. (10) Psychiatric or cognitive disorders preventing cooperation with follow-up. (11) Any other condition deemed by the investigator to interfere with trial results or increase participant risk.
Key Trial Info
Start Date :
May 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07179120
Start Date
May 1 2026
End Date
January 2 2027
Last Update
September 17 2025
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