Protocol summary
-
Study aim
-
This study is a clinical trial to investigate the effect of Alpinia officinarum Hance on spermogram factors.
-
Design
-
The target population consists of eligible patients referred to The Fatima Al-zahra Infertility Center of Babol University of Medical Sciences diagnosed with impaired spermatogenesis (Oligospermic, Teratospermic and Asthenospermic) .This study will be conducted in two groups in parallel for three months. The number of participants, 30, was considered enough according to the relevant literature. All the participants will be checked by an urologist so that they meet the criteria for impaired spermatogenesis (Oligospermia, Teratospermic and Asthenospermic); simple consecutive sampling was used and the participants gave their full consent.
-
Settings and conduct
-
The scope pf this Double-blind study will be limited to The Fatima Al-zahra Infertility Center. Before administration of drugs, a semen Analysis will be in order and the drugs will be coded as A and B. In the intervention group, 3 grams of Alpinia officinarum Hance powderin was administered in 1-gram capsules per day. The control group will receive placebo capsules (sucrose). At the end, the results of a second semen analysis (post-test) will be compared to the innital ones in terms of seminal volume, sperm count, motility and morphology.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria : idiopathic oligospermia disorder; idiopathic Teratospermic disorder; idiopathic Asthenospermia disorder.
Exclusion criteria:azoospermia; Pretesticular disorder such as endocrine disorders (hyperprolactinemia, congenital adrenal hyperplasia, ...); Chromosomal disorders such as Klinefelter, men XX, XYY; known Testicular dysfunction such as varicocele or orchitis or Cryptorchidism; Post testicular dysfunction such as the mechanical obstruction, impaired embryo transfer or functional obstruction, vasectomy and; A history of treatment for infertility in the past three month; Medication history affecting semen; History of anti-metabolite drugs ;Diabetics patients; Hypo-and hyperthyroidism patients; History of chemotherapy; A history of cerebrovascular diseases ; A history of exposure to radiation or radioactive radiation
-
Intervention groups
-
In the intervention group, 3 grams of Alpinia officinarum Hance powder will administer in 1-gram capsules per day For three months. Control group will receive placebo capsules (sucrose).
-
Main outcome variables
-
Spermogram factors including sperm volume؛ sperm count؛sperm morphology; sperm motility
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2016103130616N1
Registration date:
2017-02-10, 1395/11/22
Registration timing:
prospective
Last update:
2018-01-20, 1396/10/30
Update count:
1
-
Registration date
-
2017-02-10, 1395/11/22
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor for research, Babol University of Medical Sciences
-
Expected recruitment start date
-
2017-02-23, 1395/12/05
-
Expected recruitment end date
-
2017-06-22, 1396/04/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Comparison of Alpinia officinarum Hance and placebo in men with abnormal semen sperm
-
Public title
-
Comparison of Alpinia officinarum Hance and placebo on spermogram test
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Inclusion criteria : idiopathic oligospermia disorder; idiopathic Teratospermic disorder; idiopathic Asthenospermia disorder
Exclusion criteria:
Exclusion criteria:azoospermia; Pretesticular disorder such as endocrine disorders (hyperprolactinemia, congenital adrenal hyperplasia, ...); Chromosomal disorders such as Klinefelter, men XX, XYY; known Testicular dysfunction such as varicocele or orchitis or Cryptorchidism; Post testicular dysfunction such as the mechanical obstruction, impaired embryo transfer or functional obstruction, vasectomy and; A history of treatment for infertility in the past three month; Medication history affecting semen; History of anti-metabolite drugs ;Diabetics patients; Hypo-and hyperthyroidism patients; History of chemotherapy; A history of cerebrovascular diseases ; A history of exposure to radiation or radioactive radiation
-
Age
-
No age limit
-
Gender
-
Male
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Simple randomization
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
The participants, principal investigator, health personnel assigned to the study groups are kept blind.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2016-12-24, 1395/10/04
-
Ethics committee reference number
-
MUBABOL.HRI.REC.1395.57
Health conditions studied
1
-
Description of health condition studied
-
Sperm disorders
-
ICD-10 code
-
N50.9
-
ICD-10 code description
-
Disorder of male genital organs, unspecified
Primary outcomes
1
-
Description
-
sperm motility
-
Timepoint
-
Before the treatment & Three months after taking the drug and placebo
-
Method of measurement
-
spermogram
2
-
Description
-
Sperm morphology
-
Timepoint
-
Before the treatment & Three months after taking the drug and placebo
-
Method of measurement
-
spermogram
3
-
Description
-
Sperm Count
-
Timepoint
-
Before the treatment& Three months after taking the drug and placebo
-
Method of measurement
-
spermogram
4
-
Description
-
Sperm volume
-
Timepoint
-
Before the treatment
-
Method of measurement
-
spermogram
Secondary outcomes
1
-
Description
-
Volume of semen
-
Timepoint
-
Three months after taking the drug and placebo
-
Method of measurement
-
spermogram
2
-
Description
-
Sperm Count
-
Timepoint
-
Three months after taking the drug and placebo
-
Method of measurement
-
spermogram
3
-
Description
-
sperm motility
-
Timepoint
-
Three months after taking the drug and placebo
-
Method of measurement
-
spermogram
4
-
Description
-
Sperm morphology
-
Timepoint
-
Three months after taking the drug and placebo
-
Method of measurement
-
spermogram
Intervention groups
1
-
Description
-
In the intervention group, 3 grams of Alpinia officinarum Hance powder in will administer in 1-gram capsules per day For three months.
-
Category
-
Treatment - Drugs
2
-
Description
-
The control group, 3 grams of placebo capsules (sucrose) will receive on a daily for three months
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Vice chancellor for research, Babol University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available