Assessment the effect of Nigella sativa L. seed oil on abnormal sperm parameters in infertile men: a randomized, double-blind, placebo-controlled clinical trial
The aim of this study is to determine the effects of nigella sativa oil on the results of semen analysis in infertile men. In this clinical trial,68 men diagnosed with oligospermia and in the 25 to 40 age range, who have referred to the Infertility Research and Treatment Center in Mahdieh Hospital, are examined. These men should not be azoospermic and they also need to voluntarily consume the mentioned oil. During the treatment, they are not allowed to get any medical treatment. The semen sample of men whose sperm parameters according to WHO are low the normal rate are identified and randomly categorized in one of the control or case groups .Then the oil is prescribed to them. Each one must take a 2.5 c.c –dose, two times a dayfor 60 days. The control group must take edible paraffin as placebo and visit the center after the treatment period. Semen samples are taken from each group and then examined parameters are rechecked and compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011205204N1
Registration date:2011-06-25, 1390/04/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-25, 1390/04/04
Registrant information
Name
Maryam Kolahdooz
Name of organization / entity
Shahid Beheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 29 1226 1871
Email address
m.kolahdouz@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences, Koodakyar Ave, Daneshju Blvd, Velenjak, Tehran, IRAN
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of Nigella sativa L. seed oil on abnormal sperm parameters in infertile men: a randomized, double-blind, placebo-controlled clinical trial
Public title
Assessment the effect of nigella sativa oil on abnormal sperm parameters of infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion conditions:
20-45years-old men diagnosed with infertility for more than a year; Volunteer in taking the mixture as treatment and having the consent; Whit no history of renal, hepatic or any chronic illnesses; The volunteers are not allowed to get any medical treatments; Semen samples, with lees than 30% morphology, lees than 50% motility and lees than type (a)motility . Also with the sperm count blow 20 x ml. Exclusion conditions: Men with ozoospermia; gonad abnormalities or varicocell; suffering from urinary retention or infections; those who have taken hormone treatment; evidence of male accessory gland infection; any recent medical or surgical illness; hormone treatment for promoting fertility in the last three months; those who have time limitation (e.g. those whose wives are above 35) and cigarette smoking were excluded
Age
From 20 years old to 45 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences