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IRCT20210911052430N1 IRCT 2021-12-18 Gorgan University of Medical Sciences The effect of Daucus carota spp. carota seed extract & Persian Medicine Life style modifications on spermograms of men with idiopathic infertility 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 2021-12-11 anticipated 96 Complete https://irct.ir/trial/60468 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Idiopathic Male Infertility. Intervention 1: Control group: Group 1: Receiving clomiphene citrate tablets - Iran Hormone company (1 tablet of 50 mg per day) - for three months. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I just haven't decided yet - I have no problem with that if I keep patients anonymous
public Sayed Abolhasan Mousavi Khorshidi
The beginning of Minagol 7 - Pol building - Unit 1 - Mousavi Khorshidi house
Gorgan Iran (Islamic Republic of) 4917954379 +98 17 3254 5182 mousavi.abolhasan@goums.ac.ir Gorgan University of Medical Sciences scientific Sayed Abolhasan Mousavi khorshidi
The beginning of Minagol 7 - Pol building - Unit 1 - Mousavi Khorshidi house
Gorgan Iran (Islamic Republic of) 4917954379 +98 17 3254 5182 mousavi.abolhasan@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) 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 20 years 50 years Male 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 N46 Male infertility Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Group 1: Receiving clomiphene citrate tablets - Iran Hormone company (1 tablet of 50 mg per day) - for three months 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 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 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 Mean semen volume (cc). Timepoint: Beginning and end of the study. Method of measurement: Use a pipette or calibrated tube. Mean sperm count per milliliter of semen. Timepoint: Beginning and end of the study. Method of measurement: Sperm analyzer and neobar slide. Mean percentage of motile sperms. Timepoint: Beginning and end of the study. Method of measurement: Sperm analyzer device and simple slide. Mean sperm percentage with normal morphology. Timepoint: Beginning and end of the study. Method of measurement: Sperm analyzer device and simple slide. Sexual function. Timepoint: Beginning and end of the study. Method of measurement: Men's Sexual Health Questionnaire. Gorgan University of Medical Sciences Approved 2021-12-06 Ethics committee of Golestan Univercity of Medical Sience Hyrkan Boulevard - at the beginning of Shast Kola Road - Falsafi complex Gorgan Golestan Iran (Islamic Republic of)