Male InfertilityPhase 2NCT05290558
The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: a Randomized Controlled Trial
A Phase 2 study testing Bu Shen Yi Jing Pill in people with Male Infertility and Infertility, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
This study aims to evaluate the safety and efficacy of Bu Shen Yi Jing (BSYJ) Pill , a type of traditional Chinese medicine, in improving male subfertility and semen parameters. Read more about this study
- Who is it for?
- Ages 21 to 49 years, men only
- Conditions the study is for
- Male Infertility, Infertility, Traditional Chinese Medication (TCM)
- What is being tested?
- Bu Shen Yi Jing Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Jan 2022to 31 Dec 2024
- Phase
- Phase 2
- 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 21 to 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Duration of subfertility (both primary and secondary) ≥ 1 year;
- Any or combination of the three abnormal semen parameters, defined according to the 2010 WHO criteria, including
- Oligozoospermia, with sperm concentration less than 15 x 10^6,
- Teratozoospermia, with normal sperm morphology less than 4%, and
- Asthenozoospermia, with total sperm motility less than 40%, or progressive sperm motility less than 32%.
- Diagnosed with TCM syndrome of Kidney Deficiency Based on a prominent TCM diagnosis textbook known as TCM Diagnostics, the main symptoms patients need to fulfil for Kidney Deficiency are either nocturnal polyuria or lower back pain. In addition, patients need to fulfil any 1 of the secondary symptoms, including fatigue; dizziness; tinnitus or deafness; memory loss; excessive urination; low libido; wet dreams; premature ejaculation; presence of feverish palms and soles or night sweats; dry mouth or throat; cold intolerance or preference for warmth; poor sleep quality. Presence of both 1 main symptom and 1 secondary symptom allows for the diagnosis of the Kidney Deficiency syndrome.
- Patients who meet all three criteria mentioned above will be included in the study.
Who cannot join
- Azoospermia and severe oligoasthenoteratozoospermia;
- Aspermia;
- Varicocele;
- Recent urogenital infections;
- Y chromosome deletions;
- Abnormal karyotypes
Show all 10Show fewer
- History of chemotherapy and / or radiotherapy;
- Patients on fertility supplements or supplements marketed to improve fertility;
- Patients with uncontrolled diabetes or/and hypertension; with uncontrolled chronic medical conditions
- Patients currently already on BSYJ pills treatment
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the safety and efficacy of Bu Shen Yi Jing (BSYJ) Pill , a type of traditional Chinese medicine, in improving male subfertility and semen parameters.
Read the detailed description
Subfertility is defined as a failure to conceive after 1 year of regular unprotected intercourse. Impaired fertility affects 10 to 15% of couples and male factor is the cause of subfertility in 25 to 40% of couples. With increasing paternal age, semen volume, sperm motility and the percentage of sperm with normal morphology decreases. The majority of men who present with subfertility have either abnormal sperm density, motility or morphology, or a combination of the above, and treatment for this condition is varied and empirical.
There is a paucity of studies and randomized controlled trials to guide treatment of male factor subfertility. Various antioxidant formulations and multivitamins have been used empirically but have not been shown consistently to improve sperm counts and viability. When treatment fails, assisted reproduction will be the last resort. All assisted reproduction treatments are associated with medical, financial and emotional burden. Given the lack of proven treatment options in Western Medicine, Traditional Chinese Medicine (TCM) may provide a viable complementary treatment option. One such option is the Bu Shen Yi Jing (BSYJ) pill.
A clinical observational study conducted by the team in Singapore Thong Chai Medical on subfertile male patients with poor sperm quality and a body constitution of Kidney Deficiency showed that 2 courses of BSYJ pill over a 6 months' duration resulted in successful conception of 33% of azoospermic male patients (n = 60). In a subgroup of patients where serial sperm analysis was available (n=10), the percentage of sperm with grade A motility increased from a median of 22.6 ± 2.4% pre-treatment to 35.1 ± 3.2% post treatment (p < 0.05); and the hyaluronic binding assay improved from 33.2 ± 2.4% to 72 ± 4.6% (p < 0.05). This suggests that BSYJ pills possibly works on improving the motility of the sperms in patients having the Kidney deficiency body constitution.
As such, this study aims to validate these hypotheses and anecdotal evidence by conducting a safety and efficacy study of the BSYJ pill on a prospective cohort.
- Being tested
- Bu Shen Yi Jing Pill, Placebo Drug
- Keywords
- Infertility, Sperm, Traditional Medicine
- Medical subject headings
- Infertility, Male, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bu Shen Yi Jing PillDrug
Also called BSYJ Pill
Bu Shen Yi Jing Pill contained Radix Pseudostellaria, Fructus Lycii, Radix Et Rhizoma Salviae, Rhizoma Dioscorea, Semen Plantaginis, Semen Cuscuta, Patriniae Herba, Herba Epimedii, Radix Ophiopogonis, Fructus Rubi, Fructus Corni, Bupleurum roots, Fructus Schisandrae Chinensis, Radix Et Rhizoma Glycyrrhizae.
Dosage of the study drug is as follows: 3 pills each time, for 3 times a day, taken for 6 days every week for 1 year
Placebo DrugDrug
Also called Control drug
Placebo contains the ingredients: grounded black rice and permitted colouring. The ingredients are encapsulated within a gelatine capsule.
Dosage of the study drug is as follows: 3 pills each time, for 3 times a day, taken for 6 days every week for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients in this arm will be given a placebo pill that resembles the actual Bu Shen Yi Jing Pill. Receives: Drug: Placebo Drug |
| Bu Shen Yi Jing Pill | Active comparator | Patients in this arm will be given the BSYJ Pill. Receives: Drug: Bu Shen Yi Jing Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the change in sperm volume from baseline after treatment with BSYJ pill
From sperm samples analyses
Measured: 1 year
To determine the change in sperm morphology from baseline after treatment with BSYJ pill
From sperm samples analyses
Measured: 1 year
To determine the change in sperm motility from the baseline after treatment with BSYJ pill
From sperm samples analyses
Measured: 1 year
To determine the change in sperm concentration from the baseline after treatment with BSYJ pill
From sperm samples analyses
Measured: 1 year
Secondary outcomes (2)
To determine the clinical pregnancy rate and successful delivery rate after BSYJ pill
Defined by the number of pregnancies and subsequent actual births after commencement of BSYJ pill
Measured: 2 year
To study the safety and determine the changes in blood profile after treatment with BSYJ pill
Defined by changes in participant's full blood count, renal panel, liver function test and hormone profile.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start7 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 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.
- More trials run by KK Women's and Children's HospitalThe 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
- Model description
- This is a double-blinded randomised control trial. Participants will be randomised using block randomization by a pre-determined randomisation schedule generated by a biostatistician in block size of 4. Enrolment and assignment of intervention will be carried out by an investigator. The investigators will perform block randomization of the subjects in blocks of 4 in the ratio of 1:1 such that 2 will be assigned to treatment and 2 will be assigned to placebo.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tat Xin Ee, MD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290558
- Sponsor's protocol ID
- 2020/2019
- Status last verified
- Oct 2024
- First submitted
- 29 Dec 2021
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05290558
- Acronym / sponsor ID
- 2020/2019
- Keywords
- Infertility, Sperm, Traditional Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Mar 2022 (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.
This study aims to evaluate the safety and efficacy of Bu Shen Yi Jing (BSYJ) Pill , a type of traditional Chinese medicine, in improving male subfertility and semen parameters.
Detailed description
Subfertility is defined as a failure to conceive after 1 year of regular unprotected intercourse. Impaired fertility affects 10 to 15% of couples and male factor is the cause of subfertility in 25 to 40% of couples. With increasing paternal age, semen volume, sperm motility and the percentage of sperm with normal morphology decreases. The majority of men who present with subfertility have either abnormal sperm density, motility or morphology, or a combination of the above, and treatment for this condition is varied and empirical.
There is a paucity of studies and randomized controlled trials to guide treatment of male factor subfertility. Various antioxidant formulations and multivitamins have been used empirically but have not been shown consistently to improve sperm counts and viability. When treatment fails, assisted reproduction will be the last resort. All assisted reproduction treatments are associated with medical, financial and emotional burden. Given the lack of proven treatment options in Western Medicine, Traditional Chinese Medicine (TCM) may provide a viable complementary treatment option. One such option is the Bu Shen Yi Jing (BSYJ) pill.
A clinical observational study conducted by the team in Singapore Thong Chai Medical on subfertile male patients with poor sperm quality and a body constitution of Kidney Deficiency showed that 2 courses of BSYJ pill over a 6 months' duration resulted in successful conception of 33% of azoospermic male patients (n = 60). In a subgroup of patients where serial sperm analysis was available (n=10), the percentage of sperm with grade A motility increased from a median of 22.6 ± 2.4% pre-treatment to 35.1 ± 3.2% post treatment (p < 0.05); and the hyaluronic binding assay improved from 33.2 ± 2.4% to 72 ± 4.6% (p < 0.05). This suggests that BSYJ pills possibly works on improving the motility of the sperms in patients having the Kidney deficiency body constitution.
As such, this study aims to validate these hypotheses and anecdotal evidence by conducting a safety and efficacy study of the BSYJ pill on a prospective cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This is a double-blinded randomised control trial. Participants will be randomised using block randomization by a pre-determined randomisation schedule generated by a biostatistician in block size of 4. Enrolment and assignment of intervention will be carried out by an investigator. The investigators will perform block randomization of the subjects in blocks of 4 in the ratio of 1:1 such that 2 will be assigned to treatment and 2 will be assigned to placebo.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo DrugPatients in this arm will be given a placebo pill that resembles the actual Bu Shen Yi Jing Pill. |
| Bu Shen Yi Jing Pill | Active comparator | Drug: Bu Shen Yi Jing PillPatients in this arm will be given the BSYJ Pill. |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Duration of subfertility (both primary and secondary) ≥ 1 year;
- Any or combination of the three abnormal semen parameters, defined according to the 2010 WHO criteria, including
- Diagnosed with TCM syndrome of Kidney Deficiency Based on a prominent TCM diagnosis textbook known as TCM Diagnostics, the main symptoms patients need to fulfil for Kidney Deficiency are either nocturnal polyuria or lower back pain. In addition, patients need to fulfil any 1 of the secondary symptoms, including fatigue; dizziness; tinnitus or deafness; memory loss; excessive urination; low libido; wet dreams; premature ejaculation; presence of feverish palms and soles or night sweats; dry mouth or throat; cold intolerance or preference for warmth; poor sleep quality. Presence of both 1 main symptom and 1 secondary symptom allows for the diagnosis of the Kidney Deficiency syndrome.
- Patients who meet all three criteria mentioned above will be included in the study.
Key exclusion criteria (10 listed)
- Azoospermia and severe oligoasthenoteratozoospermia;
- Aspermia;
- Varicocele;
- Recent urogenital infections;
- Y chromosome deletions;
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 |
|---|---|---|
| Bu Shen Yi Jing PillAlso: BSYJ PillBu Shen Yi Jing Pill contained Radix Pseudostellaria, Fructus Lycii, Radix Et Rhizoma Salviae, Rhizoma Dioscorea, Semen Plantaginis, Semen Cuscuta, Patriniae Herba, Herba Epimedii, Radix Ophiopogonis, Fructus Rubi, Fructus Corni, Bupleurum roots, Fructus Schisandrae Chinensis, Radix Et Rhizoma Glycyrrhizae. Dosage of the study drug is as follows: 3 pills each time, for 3 times a day, taken for 6 days every week for 1 year | Drug | Bu Shen Yi Jing Pill |
| Placebo DrugAlso: Control drugPlacebo contains the ingredients: grounded black rice and permitted colouring. The ingredients are encapsulated within a gelatine capsule. Dosage of the study drug is as follows: 3 pills each time, for 3 times a day, taken for 6 days every week for 1 year | Drug | Placebo |
Primary outcome
To determine the change in sperm volume from baseline after treatment with BSYJ pill
Time frame: 1 year
From sperm samples analyses
To determine the change in sperm morphology from baseline after treatment with BSYJ pill
Time frame: 1 year
From sperm samples analyses
To determine the change in sperm motility from the baseline after treatment with BSYJ pill
Time frame: 1 year
From sperm samples analyses
To determine the change in sperm concentration from the baseline after treatment with BSYJ pill
Time frame: 1 year
From sperm samples analyses
2 secondary outcomes
To determine the clinical pregnancy rate and successful delivery rate after BSYJ pill
Time frame: 2 year
To study the safety and determine the changes in blood profile after treatment with BSYJ pill
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Tat Xin Ee, MD principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bu Shen Yi Jing Pill in people with Male Infertility and Infertility, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 7 inclusion and 10 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 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the change in sperm volume from baseline after treatment with BSYJ pill (time frame: 1 year). The study lists 4 primary outcomes in all. 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 10 Oct 2024.