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Can Fat-Burning Shots Boost Fertility? Comparing Weight-Loss Injections vs. Healthy Habits for Obese Men With Low Sperm Health
Male Fertility Preservation: Efficacy Evaluation of GLP-1Receptor Agonist Therapy for Infertility in Obese Males - A Multicenter Clinical Randomized Controlled Trial
Assets
GLP-1 / incretin class catch-all / Semaglutide / Tirzepatide
Listed sites
0
Recruiting sites
—
Enrollment
180
estimated
Study population
Obesity / overweight, Reproductive / infertility
Key I/E criteria
•BMI ≥28•Male
Primary endpoint
•Sperm Concentration (million/mL)
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
(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 criteria
(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.
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsChange from Baseline in Body Mass Index (BMI) at Week 32
Time frame:Baseline, Week 16, Week 32
BMI, change
change from baseline, improvement
Change from Baseline in Waist Circumference at Week 32
Time frame:Baseline, Week 16, Week 32
Waist circumference, change
change from baseline, improvement
Safety / tolerability / PK
1 endpointNumber of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Time frame:From first dose until 30 days after last dose (up to Week 48+30)
Treatment-emergent AEs (any)
event count, event
Other clinical outcomes
7 endpointsChange from Baseline in Sperm Concentration (million/mL) at Week 32 of Intervention
Time frame:Baseline and Week 32
change from baseline, improvement
Change from Baseline in Total Sperm Count at Week 32
Time frame:Baseline and Week 32
change from baseline, improvement
Change from Baseline in Sperm Motility (Progressive + Non-progressive) at Week 32
Time frame:Baseline and Week 32
change from baseline, improvement
Change from Baseline in Serum Total Testosterone Level at Week 32
Time frame:Baseline and Week 32
change from baseline, improvement
Change from Baseline in Follicle-Stimulating Hormone (FSH) Level at Week 32
Time frame:Baseline, Week 32
change from baseline, descriptive
Change from Baseline in Luteinizing Hormone (LH) Level at Week 32
Time frame:Baseline, Week 32
change from baseline, descriptive
Number of Participants Achieving Natural Pregnancy Within 48 Weeks
Time frame:Monthly during the study, up to Week 48
threshold achievement, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.