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Not yet recruitingPhase 2

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 ≥28Male

Primary endpoint

Sperm Concentration (million/mL)

Identifiers

Registered as

NCT IDNCT07179120
Org study IDKY2025-354

Timeline

Milestones

Study first posted2025-09-17actual
Last update posted2025-09-17actual
Study start2026-05-01estimated
Primary completion2026-08-12estimated
Study completion2027-01-02estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightReproductive / infertility

Eligibility

Who can enroll

Minimum age20 Years
Maximum age45 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

(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 criteria

(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.

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

Other clinical outcomes
7
Weight & body composition
2
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI) at Week 32

Time frame:Baseline, Week 16, Week 32

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Number 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 endpoints
Primary/protocol endpoint

Change from Baseline in Sperm Concentration (million/mL) at Week 32 of Intervention

Time frame:Baseline and Week 32

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Total Sperm Count at Week 32

Time frame:Baseline and Week 32

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Sperm Motility (Progressive + Non-progressive) at Week 32

Time frame:Baseline and Week 32

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Serum Total Testosterone Level at Week 32

Time frame:Baseline and Week 32

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Follicle-Stimulating Hormone (FSH) Level at Week 32

Time frame:Baseline, Week 32

change from baseline, descriptive

Secondary/protocol endpoint

Change from Baseline in Luteinizing Hormone (LH) Level at Week 32

Time frame:Baseline, Week 32

change from baseline, descriptive

Secondary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.