Effect of the “compound honey syrup” on spermatogenesis in infertile men
Design
Randomized control trial- Double Blind Study. With Control group. Sample size=76 precipitant. Randomization by R software and dual blocks.
Settings and conduct
After determining the sample size and categorization of patients in the control and treatment groups, the general information of the patients including the age and duration of infertility, medical history, as well as the results of the first semen analysis test include count , shape and sperm motility will also be recorded. Then, in treatment group, for 90 days, the compound honey syrup ( 0.5ml/kg/day) + Tab Vit E 100iu daily will be prescribed . and in control group the same proportion of placebo syrup + Vit E 100iu will be used. This study will be planned in Shariat panahi clinic. Blinding is planned carefully.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Infertility or subfertility documented with sperm analysis including sperm count, morphology and/or motility disorders
Infertility history more than one year.
patients are available
Men with age between 20 to 50 years old
exclusion criteria:
Testicular atrophy or structural diseases or congenital malformations of the genital tract
Feverish and infectious diseases
Have a history of allergic reactions to drug or placebo compounds
Varicocele
Taking chemotherapy drugs - anticoagulants - testosterone, anti-androgens
Severe systemic diseases
Intervention groups
Intervention groups include infertile men with spermatogenesis disorder(count-morphology and or motility). In both groups, vitamin E tablets are used for 90 days as a common treatment in addition to compound honey syrup (in the intervention group) and placebo with exactly the same appearance (in the control group).
Main outcome variables
sperm count
sperm morphology
sperm motility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220102053605N1
Registration date:2022-06-05, 1401/03/15
Registration timing:registered_while_recruiting
Last update:2022-06-05, 1401/03/15
Update count:0
Registration date
2022-06-05, 1401/03/15
Registrant information
Name
Farrokh Eftekhar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
feftekhar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-28, 1401/03/07
Expected recruitment end date
2022-12-28, 1401/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the “Compound honey syrup” on spermatogenesis in infertile men
Public title
Effect of the “Compound honey syrup” on spermatogenesis in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility or subfertility documented with sperm analysis :1-sperm count between 7 to 12 millions/ml AND OR .2-with any defect in morphology and motility state.
Infertility history more than one year.
patients are available
Men with age between 20 to 50 years old.
Exclusion criteria:
Testis Atrophy or other urogenital structural or congenital diseases
Infectious diseases-prostate or testis infectious diseases
Allergy to medication or placebo components
Varicocele
Chemotherapy-anti coagulant therapy-Androgen or anti androgen therapy
Sever systemic diseases
smoking or addiction
Age
From 20 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method are made with Permuted blocks .Equal block size .Two group or block A and B. After entering the study, individuals are placed in one of groups A or B. The medication is coded in exactly the same packages and the delivery assistant is based on the sealed envelope that the medication is given to the participant. And does not know whether it is a medication or a placebo. Sample size of 76 people (38 people in each group)
Blinding (investigator's opinion)
Double blinded
Blinding description
Medication and placebo are made in the company by people who are not involved in the study and will be packaged and coded in the same way. The person doing the coding will not have a role in the study until the end of the intervention. The prescribing physician, assistant, and patient will not be aware of any of the contents of the medications, and the medication code will be written on the patient's paper. (double blind).
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
Before the intervention and after the intervention( intervention period is 90 days)
Method of measurement
Semen Analysis
2
Description
sperm motility
Timepoint
Before the intervention and after the intervention( intervention period is 90 days)
Method of measurement
Semen Analysis
3
Description
sperm morphology
Timepoint
Before the intervention and after the intervention( intervention period is 90 days)
Method of measurement
Semen Analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to Vit E 100IU /day, in the experimental group, compound honey syrup(consisting of honey, ginger, cinnamon, cardamom, saffron and Alpinia officinarum) is also prescribed. Consumption of compound honey syrup, 0.5 ml/kg at 24 h in divided 3 doses(An average of 40 cc per 80 kg person). Each Dose(about 13 cc) Mixes in 100 cc of boiled and lukewarm three time a day 30 minutes after the meal. The study period is 90 days. In the first visit, the participants will be provided with the method of consumption and the daily use table of the medicine. Any ambiguity or question of the participants will be answered via SMS. They will be visited again and the possibilities will be discussed.
Category
Treatment - Drugs
2
Description
Control group: intervention includes consumption of placebo syrup in 200 ml bottles quiet the same as compound honey syrup and consisting of(water, CMC 0.7, Acesulfame potassium 0.05%, sunset yellow 0.003%, tartrazine0.002%, color additives) In addition to VIt E 100IU /day, in the control group, placebo syrup is also prescribed. Consumption of placebo, 0.5 Ml/kg at 24 h in divided 3 doses. Each Dose Mixes in 100 cc of boiled and lukewarm three time a day 30 minutes after the meal(An average of 40 cc per 80 kg person and each dose about 13 cc). The study period is 90 days. Placebo syrup is made by the pharmaceutical group of NIAK company. In the first visit, the participants will be provided with the method of consumption and daily schedule of drug use. Any ambiguity or question of the participants will be answered via SMS. Once in the middle of the course, the participant are visited and ambiguities about problems or possible complications will be discussed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariat Panahi traditional Clinic
Full name of responsible person
DR. Roshanak Mokaberinezhad
Street address
No.8, , shams Ali;Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
Rmokaberi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sponsor Vice chancellor for research, Shahid Beheshti University of Medical Sciences