Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT07179120
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT07179120
Study Brief:
Protocol Section:
NCT07179120