Obesity-related Male InfertilityPhase 2NCT07179120
Can Fat-Burning Shots Boost Fertility? Comparing Weight-Loss Injections vs. Healthy Habits for Obese Men With Low Sperm Health
A Phase 2 study testing Semaglutide (Rybelsus®), Tirzepatide and Standardized Lifestyle Intervention in people with Obesity-related Male Infertility, run by First Affiliated Hospital of Wenzhou Medical University.
Trial 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 often hard to stick with. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Obesity-related Male Infertility
- What is being tested?
- Semaglutide (Rybelsus®), Tirzepatide and Standardized Lifestyle Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 2 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- (1) Married men aged 20-45 (considering childbearing age and ensuring fertility requirements), with female spouses <40 years old and no significant infertility factors.
- Meeting China's adult obesity criteria: BMI ≥28 kg/m² or meeting central obesity criteria (waist circumference ≥90 cm).
- 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.
- Abnormal semen analysis: Baseline semen testing shows low sperm concentration or motility (e.g., sperm concentration <15×10⁶/mL or progressive motility <32%).
- Willing to undergo randomization and corresponding interventions, able to attend regular follow-ups, and provide semen and blood samples.
- Informed consent to participate in the study and signing of the informed consent form.
Who cannot join
- (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.
- Spouse has significant infertility factors (e.g., bilateral tubal blockage, severe ovulation disorders) without effective treatment, which may severely impact pregnancy outcomes.
- 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.
- Endocrine diseases affecting reproduction or sexual function: e.g., uncontrolled diabetes (HbA1c >9%) or insulin-treated diabetes, clinically significant thyroid dysfunction, hyperprolactinemia.
- 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.
- 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)
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- ; or conditions unsuitable for weight-loss medications, such as severe hepatic/renal impairment or gallstones.
- 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).
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Male Fertility Preservation: Efficacy Evaluation of GLP-1Receptor Agonist Therapy for Infertility in Obese Males - A Multicenter Clinical Randomized Controlled Trial
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 often hard to stick with. New medicines called GLP-1 receptor agonists, like semaglutide (Ozempic) and tirzepatide (Mounjaro), help people lose weight and improve health. Early studies suggest these drugs might also boost sperm health in obese men, but more proof is needed. This study tests if these drugs can safely improve fertility in obese men who are having trouble conceiving.
What will happen in this study?
Read more
This is a 48-week study at several hospitals in China. About 180 men will be randomly assigned to one of three groups:
Group 1: Standard lifestyle changes, like a healthy diet and exercise, guided by experts.
Group 2: Weekly injections of semaglutide, starting low and increasing as tolerated.
Group 3: Weekly injections of tirzepatide, starting low and increasing as tolerated.
All men will have regular check-ups, including blood tests, semen analysis, and weight measurements. We will track sperm quality, hormone levels, weight loss, and whether their partners get pregnant naturally. The study includes an 8-week adjustment period, 24 weeks of treatment, and 16 weeks of follow-up.
Who can join this study? Men aged 20-45 who are married, obese (BMI 28 or higher or waist size 90 cm or more), and have been trying to have a baby for at least a year without success due to low sperm count or poor sperm movement. Their female partners must be under 40 and have no major fertility issues. Men must be willing to attend visits and provide samples. People with serious health problems, recent use of similar drugs, or other causes of infertility (like genetic issues) cannot join.
How long will this study last? The full study lasts 48 weeks (about 11 months), with visits every 4-8 weeks, plus monthly phone check-ins for pregnancy updates.
What are the possible benefits and risks? Benefits: If the drugs work, men may lose weight, improve sperm quality, and have a better chance of their partners getting pregnant naturally. They might also feel healthier overall. Risks: Common side effects include nausea, vomiting, or diarrhea from the drugs, which usually improve over time. Rare risks include pancreas inflammation or gallbladder issues. Lifestyle changes might cause minor injuries from exercise. All side effects will be monitored closely, and participants can quit anytime. Insurance covers any study-related harm.
- Conditions
- Obesity-related Male Infertility
- Being tested
- Semaglutide (Rybelsus®), Tirzepatide, Standardized Lifestyle Intervention
- Keywords
- Obesity, Male Infertility, GLP-1 Receptor Agonists, Semaglutide, Tirzepatide, Fertility Preservation, Semen Quality, Randomized Controlled Trial, Multicenter Study
- Medical subject headings
- Obesity, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (Rybelsus®)Drug
Participants receive once-weekly subcutaneous injections of Semaglutide. The dose is titrated every 4 weeks: 0.25 mg (Weeks 1-4), 0.5 mg (Weeks 5-8), and maintained at 1.0 mg from Week 9 to Week 32. Injections are administered in the abdomen, thigh, or upper arm
TirzepatideDrug
Participants receive once-weekly subcutaneous injections of Tirzepatide. The dose is titrated every 4 weeks: 2.5 mg (Weeks 1-4), 5 mg (Weeks 5-8), 10 mg (Weeks 9-12), and maintained at 15 mg from Week 13 to Week 32. Injections are administered in the abdomen, thigh, or upper arm
Standardized Lifestyle InterventionBehavioural
Participants receive individualized intensive lifestyle management, including a calorie-restricted Mediterranean diet (daily deficit of 500 kcal), structured aerobic and resistance exercise (150 mins/week), and behavioral coaching. Delivered through weekly face-to-face sessions for the first 12 weeks, followed by bi-weekly sessions for the remaining 20 weeks. No pharmacotherapy is administered.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide Injection Therapy (Intervention A Group) | Experimental | Participants receive subcutaneous semaglutide injections titrated from 0.25mg to 1.0mg weekly over 8 weeks, maintained through week 32. Combined with standardized lifestyle intervention (identical to Control Group). Dose adjustments follow predefined tolerability criteria. Receives: Drug: Semaglutide (Rybelsus®) |
| Tirzepatide Injection Therapy (Intervention B Group) | Experimental | Participants receive subcutaneous tirzepatide injections titrated from 2.5mg to 15mg weekly over 12 weeks, maintained through week 32. Combined with standardized lifestyle intervention (identical to Control Group). Dose adjustments follow predefined tolerability criteria Receives: Drug: Tirzepatide |
| Lifestyle Modification Management (Control Group) | Experimental | Participants receive standardized intensive lifestyle intervention including personalized dietary guidance (calorie-restricted Mediterranean diet), structured aerobic/resistance exercise protocol (150 mins/week), and behavioral coaching. No pharmacotherapy is administered. Interventions are delivered through weekly sessions for first 12 weeks followed by biweekly sessions. Receives: Behavioral: Standardized Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Sperm Concentration (million/mL) at Week 32 of Intervention
Sperm concentration is measured by standardized laboratory analysis of semen samples. Values are reported in million sperm cells per milliliter (million/mL). Higher values indicate better spermatogenesis function. The World Health Organization (WHO) reference lower limit for normal concentration is ≥15 million/mL. Change is calculated as: (Week 32 value - Baseline value)
Measured: Baseline and Week 32
Secondary outcomes (9)
Change from Baseline in Total Sperm Count at Week 32
Total sperm count is calculated from semen volume and sperm concentration. Values are reported in millions. Higher values indicate better spermatogenesis function.
Measured: Baseline and Week 32
Change from Baseline in Sperm Motility (Progressive + Non-progressive) at Week 32
Sperm motility assesses the percentage of sperm moving (progressive + non-progressive). Values range from 0% to 100%. Higher percentages indicate better sperm function.
Measured: Baseline and Week 32
Change from Baseline in Serum Total Testosterone Level at Week 32
Serum total testosterone is measured via chemiluminescence immunoassay. Reported in nanomoles per liter (nmol/L). Normal adult male range is typically 10-35 nmol/L.
Measured: Baseline and Week 32
Change from Baseline in Follicle-Stimulating Hormone (FSH) Level at Week 32
Serum FSH concentration is measured by chemiluminescence immunoassay, reported in international units per liter (IU/L). It assesses pituitary-gonadal axis function. Normal reference range for adult males is typically 1.5-12.4 IU/L.
Measured: Baseline, Week 32
Change from Baseline in Luteinizing Hormone (LH) Level at Week 32
Serum LH concentration is measured by chemiluminescence immunoassay, reported in international units per liter (IU/L). It assesses pituitary-gonadal axis function. Normal reference range for adult males is typically 1.7-8.6 IU/L.
Measured: Baseline, Week 32
Change from Baseline in Body Mass Index (BMI) at Week 32
Body weight is measured using a calibrated digital scale, reported in kilograms (kg). Change is calculated as post-intervention value minus baseline value. A negative value indicates weight loss.
Measured: Baseline, Week 16, Week 32
Change from Baseline in Waist Circumference at Week 32
Waist circumference is measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest using a non-elastic tape, reported in centimeters (cm). It assesses central obesity. A value ≥90 cm in Asian males indicates increased health risk.
Measured: Baseline, Week 16, Week 32
Number of Participants Achieving Natural Pregnancy Within 48 Weeks
Natural pregnancy is confirmed by a positive serum β-hCG test (>5 mIU/mL) followed by transvaginal ultrasound verification of an intrauterine gestational sac. It is reported as a binary outcome (Yes/No) for each participant.
Measured: Monthly during the study, up to Week 48
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
All adverse events occurring after the initiation of treatment are assessed by the investigator for severity (Grade 1-5 Mild to Death) and relationship to study intervention according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: From first dose until 30 days after last dose (up to Week 48+30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 May 2026 (estimated)
- Primary completion12 Aug 2026 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity-related Male InfertilityStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179120
- Sponsor's protocol ID
- KY2025-354
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Fertility Preservation: Efficacy Evaluation of GLP-1Receptor Agonist Therapy for Infertility in Obese Males - A Multicenter Clinical Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07179120
- Acronym / sponsor ID
- KY2025-354
- Conditions
- Obesity-related Male Infertility
- Keywords
- Obesity, Male Infertility, GLP-1 Receptor Agonists, Semaglutide, Tirzepatide, Fertility Preservation, Semen Quality, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 12 Aug 2026 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 often hard to stick with. New medicines called GLP-1 receptor agonists, like semaglutide (Ozempic) and tirzepatide (Mounjaro), help people lose weight and improve health. Early studies suggest these drugs might also boost sperm health in obese men, but more proof is needed. This study tests if these drugs can safely improve fertility in obese men who are having trouble conceiving.
What will happen in this study?
This is a 48-week study at several hospitals in China. About 180 men will be randomly assigned to one of three groups:
Group 1: Standard lifestyle changes, like a healthy diet and exercise, guided by experts.
Group 2: Weekly injections of semaglutide, starting low and increasing as tolerated.
Group 3: Weekly injections of tirzepatide, starting low and increasing as tolerated.
All men will have regular check-ups, including blood tests, semen analysis, and weight measurements. We will track sperm quality, hormone levels, weight loss, and whether their partners get pregnant naturally. The study includes an 8-week adjustment period, 24 weeks of treatment, and 16 weeks of follow-up.
Who can join this study? Men aged 20-45 who are married, obese (BMI 28 or higher or waist size 90 cm or more), and have been trying to have a baby for at least a year without success due to low sperm count or poor sperm movement. Their female partners must be under 40 and have no major fertility issues. Men must be willing to attend visits and provide samples. People with serious health problems, recent use of similar drugs, or other causes of infertility (like genetic issues) cannot join.
How long will this study last? The full study lasts 48 weeks (about 11 months), with visits every 4-8 weeks, plus monthly phone check-ins for pregnancy updates.
What are the possible benefits and risks? Benefits: If the drugs work, men may lose weight, improve sperm quality, and have a better chance of their partners getting pregnant naturally. They might also feel healthier overall. Risks: Common side effects include nausea, vomiting, or diarrhea from the drugs, which usually improve over time. Rare risks include pancreas inflammation or gallbladder issues. Lifestyle changes might cause minor injuries from exercise. All side effects will be monitored closely, and participants can quit anytime. Insurance covers any study-related harm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Injection Therapy (Intervention A Group) | Experimental | Drug: Semaglutide (Rybelsus®)Participants receive subcutaneous semaglutide injections titrated from 0.25mg to 1.0mg weekly over 8 weeks, maintained through week 32. Combined with standardized lifestyle intervention (identical to Control Group). Dose adjustments follow predefined tolerability criteria. |
| Tirzepatide Injection Therapy (Intervention B Group) | Experimental | Drug: TirzepatideParticipants receive subcutaneous tirzepatide injections titrated from 2.5mg to 15mg weekly over 12 weeks, maintained through week 32. Combined with standardized lifestyle intervention (identical to Control Group). Dose adjustments follow predefined tolerability criteria |
| Lifestyle Modification Management (Control Group) | Experimental | Behavioral: Standardized Lifestyle InterventionParticipants receive standardized intensive lifestyle intervention including personalized dietary guidance (calorie-restricted Mediterranean diet), structured aerobic/resistance exercise protocol (150 mins/week), and behavioral coaching. No pharmacotherapy is administered. Interventions are delivered through weekly sessions for first 12 weeks followed by biweekly sessions. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- (1) Married men aged 20-45 (considering childbearing age and ensuring fertility requirements), with female spouses <40 years old and no significant infertility factors.
Key exclusion criteria (9 listed)
- (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.
- ; or conditions unsuitable for weight-loss medications, such as severe hepatic/renal impairment or gallstones.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide (Rybelsus®)Participants receive once-weekly subcutaneous injections of Semaglutide. The dose is titrated every 4 weeks: 0.25 mg (Weeks 1-4), 0.5 mg (Weeks 5-8), and maintained at 1.0 mg from Week 9 to Week 32. Injections are administered in the abdomen, thigh, or upper arm | Drug | Semaglutide Injection Therapy (Intervention A Group) |
| TirzepatideParticipants receive once-weekly subcutaneous injections of Tirzepatide. The dose is titrated every 4 weeks: 2.5 mg (Weeks 1-4), 5 mg (Weeks 5-8), 10 mg (Weeks 9-12), and maintained at 15 mg from Week 13 to Week 32. Injections are administered in the abdomen, thigh, or upper arm | Drug | Tirzepatide Injection Therapy (Intervention B Group) |
| Standardized Lifestyle InterventionParticipants receive individualized intensive lifestyle management, including a calorie-restricted Mediterranean diet (daily deficit of 500 kcal), structured aerobic and resistance exercise (150 mins/week), and behavioral coaching. Delivered through weekly face-to-face sessions for the first 12 weeks, followed by bi-weekly sessions for the remaining 20 weeks. No pharmacotherapy is administered. | Behavioural | Lifestyle Modification Management (Control Group) |
Primary outcome
Change from Baseline in Sperm Concentration (million/mL) at Week 32 of Intervention
Time frame: Baseline and Week 32
Sperm concentration is measured by standardized laboratory analysis of semen samples. Values are reported in million sperm cells per milliliter (million/mL). Higher values indicate better spermatogenesis function. The World Health Organization (WHO) reference lower limit for normal concentration is ≥15 million/mL. Change is calculated as: (Week 32 value - Baseline value)
9 secondary outcomes
Change from Baseline in Total Sperm Count at Week 32
Time frame: Baseline and Week 32
Change from Baseline in Sperm Motility (Progressive + Non-progressive) at Week 32
Time frame: Baseline and Week 32
Change from Baseline in Serum Total Testosterone Level at Week 32
Time frame: Baseline and Week 32
Change from Baseline in Follicle-Stimulating Hormone (FSH) Level at Week 32
Time frame: Baseline, Week 32
Change from Baseline in Luteinizing Hormone (LH) Level at Week 32
Time frame: Baseline, Week 32
Change from Baseline in Body Mass Index (BMI) at Week 32
Time frame: Baseline, Week 16, Week 32
Change from Baseline in Waist Circumference at Week 32
Time frame: Baseline, Week 16, Week 32
Number of Participants Achieving Natural Pregnancy Within 48 Weeks
Time frame: Monthly during the study, up to Week 48
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide (Rybelsus®), Tirzepatide and Standardized Lifestyle Intervention in people with Obesity-related Male Infertility, run by First Affiliated Hospital of Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhigang Wu (+86 13676467276, andrologywzg@wmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Sperm Concentration (million/mL) at Week 32 of Intervention (time frame: Baseline and Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.