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Comparison of the effect of Daucus carota ssp. carota seed extract & Persian Medicine Life style modifications with Clomiphene citrate on spermograms of men with idiopathic infertility: a randomized controlled trial

Protocol summary

Study aim
Comparison of the effect of Daucus carota ssp. carota seed extract & Persian medicine life style modifications with Clomiphene citrate on spermograms of men with idiopathic infertility: a randomized controlled trial
Design
Randomized controlled clinical trial with parallel groups, double-blind, phase 3 on 96 patients. Randomization was performed by block method
Settings and conduct
The study is performed on infertile and eligible men who are referred to the Nahal Infertility Clinic of Sayad Shirazi Center in Gorgan. Daucus carota seed extract capsuls and clomiphene tablets are prepared and then enclosed in opac boxes to hide the allocation, which has nothing to do with this research. Which is provided to the research samples based on the table of random numbers created. The list of codes is confidential and is kept confidential until the data is analyzed. In this study, the researcher and the subjects will not know the contents of the packages.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men aged 20-50 years with idiopathic infertility (oligoasthenotratosospermia), with normal hormonal tests and BMI≤30kg / m2 who have agreed to be included in the study and have been visited and referred by a urologist Exclusion criteria: Includes any disorder or medication that indicates secondary infertility
Intervention groups
A = Receiving clomiphene tablets (1 tablet of 50 mg per day) B = Receiving clomiphene tablets and Daucus carota seed extract capsules (6 capsules of 700 mg per day - devided to three doses) C = Receiving clomiphene tablets and lifestyle modifications of Iranian medicine D = Receiving clomiphene tablets and capsules of Daucus carota seed extract with lifestyle modifications of Iranian medicine The intervention will be performed in all groups for three months
Main outcome variables
Semen volume Sperm count Sperm movement Sperm morphology Sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210911052430N1
Registration date: 2021-12-18, 1400/09/27
Registration timing: registered_while_recruiting

Last update: 2021-12-18, 1400/09/27
Update count: 0
Registration date
2021-12-18, 1400/09/27
Registrant information
Name
Sayed abolhasan Mousavi khorshidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 5182
Email address
mousavi.abolhasan@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2023-12-11, 1402/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Daucus carota ssp. carota seed extract & Persian Medicine Life style modifications with Clomiphene citrate on spermograms of men with idiopathic infertility: a randomized controlled trial
Public title
The effect of Daucus carota spp. carota seed extract & Persian Medicine Life style modifications on spermograms of men with idiopathic infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Men 20-50 years with at least one year of idopatic infertility disorder 2. Existence of at least one of the three criteria related to sperm disorder (number - motility - morphology) - Existence of idiopathic oligospermia disorder according to WHO criteria (Existence of sperm count less than 15 million per ml and total less than 39 million in semen It is called oligospermia) - Presence of idiopathic stenospermia according to WHO criteria (if the percentage of sperm with normal motility in semen is less than 40% is called stenospermia). Has a normal morphology in semen less than 4% is called teratospermia) 3. Patients with varicocele who has been 6 month since their surgery and have not been able to conceive 4. Normal testosterone, serum gonadotropins and prolactin 5. Normal thyroid hormones (no hypo or hypothyroidism) 6. BMI≤30kg/m2 7. Satisfaction of the patient
Exclusion criteria:
1- Severe oligospermia or azoospermia (less than 5 million sperm per milliliter) 2- History of epididymitis, prostatitis, trauma, testicular torsion, inguinal scrotal surgery 3- Pretesticular disorders such as endocrine diseases (hyperprolactinemia, congenital adrenal hyperplasia ...) 4- Known Testicular disorders such as varicocele or orchitis or cryptorchidism 5- Known post testicular disorders such as mechanical obstruction, impaired egg transfer or functional obstruction, vasectomy, etc. 6- History of taking anti-metabolites and alkylators 7- History of cancer and chemotherapy and radiotherapy treatments 8- Having chronic diseases such as diabetes and cardiovascular disorders 9- Infection of the genital tract 10- Taking cytotoxic, immunosuppressive, androgen or anti-androgen drugs and alcohol or opium addiction 11- Having liver failure 12- Having kidney failure 13- History of receiving medicine for infertility treatment in the last three months 14- History of receiving drugs affecting semen in the last three months
Age
From 20 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Random block allocation: For random allocation using blocks of 8, according to the number of samples, 12 blocks of 8 should be generated. For this purpose, from among possible 8-blocks, the number of which is 2520, based on uniform random selection, a random sequence obtained from 12 blocks of 8 was produced as follows: BADABCCD, ACDABBCD, AABCDBCD, ABDCACBD, BACDABCD, C ABDCABD, ABDCACBD, DABCDABC, CABDABCD, BADCACBD, CBABDACD, DABCACBD According to the above block, 96 envelopes are prepared and in each envelope, according to the table below, we put the letters D, C, B, A and number the envelopes from 1 to 96. The person delivering the envelopes to the patients does not know what is inside, in addition to the patient, the prescriber also does not know how to allocate patients. Patients fit the letter inside the envelope, they are in the desired group according to the following division. A = Receiving clomiphene tablets B = Receiving clomiphene tablets and Daucus carota seed extract capsules C = Receiving clomiphene tablets and lifestyle modifications of persian medicine D = Receiving clomiphene tablets and Daucus carota seed extract capsuls with lifestyle modifications of persian medicine The number of each patient in statistical examinations will be the same as the envelope number.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person delivering the envelopes to the patients does not know what is inside. Therefore, in addition to the patient, the prescriber also does not know how to allocate patients. Patients fit the letter inside the envelope, they are in the desired group according to the following division. A = Receiving clomiphene tablets B = Receiving clomiphene tablets and Daucus carota seed extract capsules C = Receiving clomiphene tablets and lifestyle modifications of persian medicine D = Receiving clomiphene tablets and Daucus carota seed extract capsules with lifestyle modifications of persain medicine The number of each patient in statistical examinations will be the same as the envelope number.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan Univercity of Medical Sience
Street address
Hyrkan Boulevard - at the beginning of Shast Kola Road - Falsafi complex
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2021-12-06, 1400/09/15
Ethics committee reference number
IR.GOUMS.REC.1400.319

Health conditions studied

1

Description of health condition studied
Idiopathic Male Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility

Primary outcomes

1

Description
Mean semen volume (cc)
Timepoint
Beginning and end of the study
Method of measurement
Use a pipette or calibrated tube

2

Description
Mean sperm count per milliliter of semen
Timepoint
Beginning and end of the study
Method of measurement
Sperm analyzer and neobar slide

3

Description
Mean percentage of motile sperms
Timepoint
Beginning and end of the study
Method of measurement
Sperm analyzer device and simple slide

4

Description
Mean sperm percentage with normal morphology
Timepoint
Beginning and end of the study
Method of measurement
Sperm analyzer device and simple slide

5

Description
Sexual function
Timepoint
Beginning and end of the study
Method of measurement
Men's Sexual Health Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Group 1: Receiving clomiphene citrate tablets - Iran Hormone company (1 tablet of 50 mg per day) - for three months
Category
Treatment - Drugs

2

Description
Intervention group: Group 2: Receiving clomiphene citrate tablets - Iran Hormone company (1 tablet of 50 mg per day) and Daucus carota seed extract capsules - Golestan Univercity of Medical Science (6 capsuls of 700 mg per day - devided to three doses) - for three months
Category
Treatment - Drugs

3

Description
Intervention group: Group 3: Receiving clomiphene citrate tablets - Iran Hormone company (1 tablet of 50 mg per day) and lifestyle modifications of persian medicine - three months
Category
Treatment - Drugs

4

Description
Intervention group: Group 4: Receiving clomiphene citrate tablets - Iran Hormone company (1 tablet of 50 mg per day) and Daucus carota seed extract capsules - Golestan Univercity of Medical Science (6 capsuls of 700 mg per day - devided to three doses) along with lifestyle modifications of persian medicine - for three months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayad Shirazi Educational - Medical Center of Gorgan
Full name of responsible person
Alireza Norouzi
Street address
Sayad Shirazi Boulevard
City
Gorgan
Province
Golestan
Postal code
49178677439
Phone
+98 17 3225 1502
Email
infosayyad@goums.ac.ir
Web page address
https://goums.ac.ir/index.php?slc_lang=fa&sid=78

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Abdorreza Fazel
Street address
Hirkan Boulevard
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3247 0110
Fax
+98 17 3247 0110
Email
Ravabetomoomi@goums.ac.ir
Web page address
https://goums.ac.ir//
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sayed Abolhasan Mousavi Khorshidi
Position
Ph.D Candidate of Persian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
The beginning of Minagol 7 - Pol building - Unit 1 - Mousavi Khorshidi house
City
Gorgan
Province
Golestan
Postal code
4917954379
Phone
+98 17 3254 5182
Fax
Email
mousavi.abolhasan@goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sayed Abolhasan Mousavi khorshidi
Position
Ph.D Candidate of Persian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
The beginning of Minagol 7 - Pol building - Unit 1 - Mousavi Khorshidi house
City
Gorgan
Province
Golestan
Postal code
4917954379
Phone
+98 17 3254 5182
Fax
Email
mousavi.abolhasan@goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sayed Abolhasan Mousavi khorshidi
Position
Ph.D Candidate of Persian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
The beginning of Minagol 7 - Pol building - Unit 1 - Mousavi Khorshidi house
City
Gorgan
Province
Golestan
Postal code
4917954379
Phone
+98 17 3254 5182
Fax
Email
mousavi.abolhasan@goums.ac.ir

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
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