Male InfertilityEarly Phase 1NCT05792813
Efficacy and Safety of Linggui Yangyuan Paste in Patients With Male Infertility
A Early Phase 1 study testing LGYY, LGYY mimetic and WZYZ in people with Male Infertility and Asthenozoospermia, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Trial summary
Male infertility affects millions of males worldwide and is rising in prevalence due to social and environmental conditions. Asthenozoospermia (AZS) and oligoasthenozoospermia (OA) are the major causes of male infertility. Read more about this study
- Who is it for?
- Ages 22 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility, Asthenozoospermia, Oligoasthenozoospermia
- What is being tested?
- LGYY, LGYY mimetic and WZYZ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 22 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participants must meet all following criteria at the time of randomization to be eligible for recruitment :
- Study participants met the diagnostic criteria for male infertility 1)inability to have a child after at least 1 year of marriage with regular sexual life and without using any preventive methods 2)normal fertile female partner
- Study participants met the diagnostic criteria for AZS or OA
- For AZS:
- sperm concentration ≥15 × 106/ mL
- PR <32%
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- For OA:
- sperm concentration <15 × 106/ mL
- PR <32% (3) Study participants met the TCM diagnosis criteria for kidney deficiency and blood stasis (4) Men aged 22 to 45 years (5) The participants signed informed consent forms
Who cannot join
- The trial exclusion criteria included any of the following:
- infertility is caused by the inability to complete sexual intercourse, including but not limited to erectile dysfunction or ejaculatory disorders
- with infertility caused by organic lesions of the reproductive system
- with reproductive system infection, such as chlamydia trachomatis or mycoplasma infection
- with palpable varicocele
- with abnormal and clinical significance of sex hormone (FSH, LH, T)
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- complicated with liver and kidney dysfunction, severe basic diseases such as diabetes, cardiovascular and cerebrovascular diseases, mental diseases, malignant tumors, or serious organic diseases
- with a history of allergy to any medicine or ingredients used in this study
- receive other relevant treatment for the disease 2 weeks before treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Male infertility affects millions of males worldwide and is rising in prevalence due to social and environmental conditions. Asthenozoospermia (AZS) and oligoasthenozoospermia (OA) are the major causes of male infertility. The diagnosis of male infertility has a negative effect on men's physical and psychological status, poses a threat to their social relationships, lowers self-esteem, and disrupts family harmony. At present, the treatment of ASZ and OA are all mostly empirical, including antioxidants, endocrine therapy, and anti-infection. However, there are still limitations due to inefficiencies. Linggui Yangyuan paste (LGYY), a traditional Chinese compound herbal past, had been used to treat ASZ and OA for several years at the Xiyuan Hospital of China Academy of Chinese Medical Sciences. The investigators designed this program to study the efficacy and safety of LGYY for the treatment of patients with male infertility (AZS and OA).
- Conditions
- Male Infertility, Asthenozoospermia, Oligoasthenozoospermia
- Being tested
- LGYY, LGYY mimetic, WZYZ, WZYZ mimetic
- Medical subject headings
- Infertility, Male, Asthenozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGYYDrug
LGYY = Linggui Yangyuan paste
LGYY mimeticDrug
LGYY = Linggui Yangyuan paste
WZYZDrug
WZYZ= Wuzi Yanzong oral solution
WZYZ mimeticDrug
WZYZ= Wuzi Yanzong oral solution
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | LGYY+ WZYZ mimetic Receives: Drug: LGYY; Drug: WZYZ mimetic |
| Control group | Active comparator | WZYZ + LGYY mimetic Receives: Drug: LGYY mimetic; Drug: WZYZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment
TPMSC change from baseline to post-treatment
Measured: Baseline, 12 weeks
Secondary outcomes (8)
The total sperm count change from baseline to post-treatment
the total sperm count change from baseline to post-treatment
Measured: Baseline, 4, 8, 12 weeks
semen volume change from baseline to post-treatment
- semen volume
Measured: Baseline, 4, 8, 12 weeks
sperm density change from baseline to post-treatment
- sperm density
Measured: Baseline, 4, 8, 12 weeks
PR rate change from baseline to post-treatment
- Semen parameter PR rate
Measured: Baseline, 4, 8, 12 weeks
PR+NP rate change from baseline to post-treatment
- PR+NP rate
Measured: Baseline, 4, 8, 12 weeks
Chinese Medicine Symptoms Score (CMSS) change from baseline to post-treatment
Scores range from 0 to 33 with higher scores indicating greater burden of symptoms.
Measured: Baseline, 4, 8, 12 weeks of treatment and 12 weeks of follow-up (24 week)
spouse pregnancy rate
difference in the number of pregnancies
Measured: Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)
time to pregnancy
The time required for pregnancy in this study
Measured: Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Chengdu Fifth People's Hospital, Affiliated Hospital of Nanjing University of Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792813
- Sponsor's protocol ID
- Xiyuannanke
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- ClinicalTrials.gov ID
- NCT05792813
- Acronym / sponsor ID
- Xiyuannanke
- Conditions
- Male Infertility, Asthenozoospermia, Oligoasthenozoospermia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Chengdu Fifth People's Hospital, Affiliated Hospital of Nanjing University of Chinese Medicine
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Mar 2023 (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.
Male infertility affects millions of males worldwide and is rising in prevalence due to social and environmental conditions. Asthenozoospermia (AZS) and oligoasthenozoospermia (OA) are the major causes of male infertility. The diagnosis of male infertility has a negative effect on men's physical and psychological status, poses a threat to their social relationships, lowers self-esteem, and disrupts family harmony. At present, the treatment of ASZ and OA are all mostly empirical, including antioxidants, endocrine therapy, and anti-infection. However, there are still limitations due to inefficiencies. Linggui Yangyuan paste (LGYY), a traditional Chinese compound herbal past, had been used to treat ASZ and OA for several years at the Xiyuan Hospital of China Academy of Chinese Medical Sciences. The investigators designed this program to study the efficacy and safety of LGYY for the treatment of patients with male infertility (AZS and OA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: LGYY, Drug: WZYZ mimeticLGYY+ WZYZ mimetic |
| Control group | Active comparator | Drug: LGYY mimetic, Drug: WZYZWZYZ + LGYY mimetic |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The participants must meet all following criteria at the time of randomization to be eligible for recruitment :
- sperm concentration ≥15 × 106/ mL
- PR <32%
- sperm concentration <15 × 106/ mL
- PR <32% (3) Study participants met the TCM diagnosis criteria for kidney deficiency and blood stasis (4) Men aged 22 to 45 years (5) The participants signed informed consent forms
Key exclusion criteria (9 listed)
- The trial exclusion criteria included any of the following:
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 |
|---|---|---|
| LGYYLGYY = Linggui Yangyuan paste | Drug | Experimental group |
| LGYY mimeticLGYY = Linggui Yangyuan paste | Drug | Control group |
| WZYZWZYZ= Wuzi Yanzong oral solution | Drug | Control group |
| WZYZ mimeticWZYZ= Wuzi Yanzong oral solution | Drug | Experimental group |
Primary outcome
Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment
Time frame: Baseline, 12 weeks
TPMSC change from baseline to post-treatment
8 secondary outcomes
The total sperm count change from baseline to post-treatment
Time frame: Baseline, 4, 8, 12 weeks
semen volume change from baseline to post-treatment
Time frame: Baseline, 4, 8, 12 weeks
sperm density change from baseline to post-treatment
Time frame: Baseline, 4, 8, 12 weeks
PR rate change from baseline to post-treatment
Time frame: Baseline, 4, 8, 12 weeks
PR+NP rate change from baseline to post-treatment
Time frame: Baseline, 4, 8, 12 weeks
Chinese Medicine Symptoms Score (CMSS) change from baseline to post-treatment
Time frame: Baseline, 4, 8, 12 weeks of treatment and 12 weeks of follow-up (24 week)
spouse pregnancy rate
Time frame: Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)
time to pregnancy
Time frame: Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LGYY, LGYY mimetic and WZYZ in people with Male Infertility and Asthenozoospermia, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences.
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 9 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shengjing liu, Phd. (+86 01062835134, liu-shengjing@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment (time frame: Baseline, 12 weeks). 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 27 Apr 2023.