Infertility Clinical Trial
Official title:
The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: a Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 21 Years to 49 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Azoospermia and severe oligoasthenoteratozoospermia; - Aspermia; - Varicocele; - Recent urogenital infections; - Y chromosome deletions; - Abnormal karyotypes - 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | KK Women's and Children's Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To assess the common side effects of the BSYJ pill | Participant reported symptoms of excessive heat syndrome such as ulcers and mouth dryness. | 1 year | |
Other | To assess the common gastrointestinal side effects of the BSYJ pill | Participant reported symptoms of gastrointestinal symptoms such as indigestion and appetite reduction. | 1 year | |
Other | To evaluate safety profile of BSYJ pill | Participants will be assessed frequently to pick up any side effects noted after commencement of BSYJ pill | Up to 1 year after recruitment | |
Other | Change from baseline severity based on TCM symptom scoring questionnaire | As BSYJ pills target the TCM syndrome of Kidney Qi deficiency, symptoms related to Kidney Qi deficiency syndrome, which includes frequent urination and back pain, fatigue and dizziness, may be improved through this research. | 1 year | |
Other | Number of participants with improvement in TCM syndrome of Kidney Qi deficiency from baseline according to the TCM symptom scoring questionnaire Stagnation | As BSYJ pills target the TCM syndrome of Kidney Qi deficiency, symptoms related to Kidney Qi deficiency syndrome, which includes frequent urination and back pain, fatigue and dizziness, may be improved through this research. | 1 year | |
Other | Patient's basic demographics | Defined by age, ethnicity, marital status | 1 year | |
Other | Patient's partner's basic demographics | Defined by age, ethnicity, marital status | 1 year | |
Other | Patients's anthropometry | Defined by height, weight and body mass index based on weight (kg) /height (m)2 | 1 year | |
Other | Number of participants who smoke | Self-reported | 1 year | |
Other | Number of participants who take alcohol regularly | Self-reported based on the amount and frequency of alcohol intake | 1 year | |
Other | Number of participants who have dietary restrictions | Self-reported | 1 year | |
Other | Number of participants with occupational exposures to chemicals | Self-reported | 1 year | |
Other | Number of participants with exposure to hot baths or jacuzzi | Self-reported | 1 year | |
Other | Number of participants who uses recreational drugs | Self-reported | 1 year | |
Other | Number of participants who exercise regularly | Self-reported | 1 year | |
Other | Number of patients with significant medical history | Self-reported details of medical history | 1 year | |
Other | Number of patients with significant surgical history | Self-reported details of surgical history | 1 year | |
Other | Number of patients on regular medications | Self-reported details of types of regular medications | 1 year | |
Other | Number of patients with drug allergies | Self-reported details of drug allergies | 1 year | |
Other | Number of patients who take supplements | Self-reported details of the type of supplements taken | 1 year | |
Other | Number of patients who take steroids | Self-reported | 1 year | |
Other | Number of patients with previous history of sexually transmitted disease | Self-reported details of sexually transmitted disease | 1 year | |
Other | Number of patients with previous history of genital trauma | Self-reported details of genital trauma | Since birth | |
Other | Patient's fertility history | Determined by the number of years of attempts at conception, sexual intercourse frequency, number of paternity (including current and/or previous partners), previous fertility treatments and medications | 1 year | |
Other | Patient's partner's fertility history | Determined by the number of years of attempts at conception, sexual intercourse frequency, number of maternity (including current and/or previous partners), previous fertility treatments and medications, and menstrual history | 1 year | |
Primary | To determine the change in sperm volume from baseline after treatment with BSYJ pill | From sperm samples analyses | 1 year | |
Primary | To determine the change in sperm morphology from baseline after treatment with BSYJ pill | From sperm samples analyses | 1 year | |
Primary | To determine the change in sperm motility from the baseline after treatment with BSYJ pill | From sperm samples analyses | 1 year | |
Primary | To determine the change in sperm concentration from the baseline after treatment with BSYJ pill | From sperm samples analyses | 1 year | |
Secondary | 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 | 2 year | |
Secondary | 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. | 1 year |
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