This study is a clinical trial to investigate the effect of Alpinia officinarum Hance on spermogram factors. 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. The scope pf this unilateral 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016103130616N1
Registration date:2017-02-10, 1395/11/22
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Fatemeh Kolangi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4730
Email address
f.kolangi@mubabol.ac.ir
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 : 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
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
University of Medical Sciences, Ganjafrooz Street
City
Babol
Postal code
47176-47745
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
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
Recruitment centers
1
Recruitment center
Name of recruitment center
The Fatima Al-zahra Research Center for Fertility and Infertility
Full name of responsible person
Fatemeh Kolangi
Street address
University of Medical Sciences, Ganjafrooz Street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Doctor Ali Akbar Moghadam Nia
Street address
Vice chancellor for research,University of Medical Sciences, Ganjafrooz Street
City
Babol
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahra Memariani
Position
Traditional Pharmacist
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafrooz Street
City
Babol
Postal code
Phone
+98 11 3219 4730
Fax
Email
z.memariani@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyyedali Mozaffarpour
Position
Assistant Professor Faculty
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafrooz Street
City
Babol
Postal code
Phone
+98 11 3219 4730
Fax
Email
seyyedali1357@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Kolangi
Position
PHD Student of Traditional Medicine
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafrooz Street
City
babol
Postal code
47176-47745
Phone
+98 11 3219 4730
Fax
+98 11 3219 4728
Email
F.kolangi@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)