scholarly journals The effects of Vitamin D3 supplementation on Spermatogram and endocrine factors in asthenozoospermia infertile men: a randomized, triple blind, placebo-controlled clinical trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Leila Maghsoumi-Norouzabad ◽  
Ahmad Zare Javid ◽  
Anahita Mansoori ◽  
Mohammadreza Dadfar ◽  
Amirarsalan Serajian
Keyword(s):  
Clinical Trial ◽  
Sperm Motility ◽  
Vitamin D3 ◽  
Sperm Count ◽  
Demographic Data ◽  
Sperm Parameters ◽  
Sex Hormone Binding Globulin ◽  
Controlled Clinical Trial ◽  
Total Testosterone ◽  
Infertile Men

Abstract Objective Evaluate the effects of vitamin D3 (VD3) on sperm parameters and endocrine markers in infertile men with asthenozoospermia. Materials and methods This randomized, triple-masking, placebo-controlled clinical trial conducted on 86 asthenozoospermia infertile men with serum 25 hydroxy vitamin D3 (25(OH)VD3) < 30 ng/ml in the infertility clinic of Ahvaz Jahad daneshgahi, Iran. Patients were randomly allocated to groups A and B, who received daily 4000 IU VD3 and matching placebo respectively for 3 months. Demographic data, dietary intake, physical activity, sun exposure, anthropometric indices, serum 25(OH)VD3, luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone (T), estradiol (E2),, sex hormone-binding globulin (SHBG), free androgen index (FAI = T/SHBG. 100), T/LH and T/E2 ratios, prolactin (PRO), parathyroid hormone (PTH), osteocalcin (OCN), phosphorus and sperm parameters were assessed. Results Three months VD3 supplementation with 4000 IU/day had no significant effects body weight, body mass index (BMI), waist circumference (WC), body fat (BF), serum, OCN, LH, FSH, T, E2, SHBG, PRO, T/E2 ratio, FAI, semen volume, sperm count and normal sperm morphology. It increases serum 25(OH)VD3, PTH and phosphorus and seminal and serum calcium, T/LH ratio and total and progressive sperm motility and decreased significantly compared to the baseline and placebo group. Conclusion VD3 supplementation may affect sperm motility in men with asthenozoospermia and serum 25(OH)VD3 < 30 ng/ml. Trial registration Iran Clinical Trials Registry, ID: IRCT20151128025274N4, registered on 28 March 2018, URL of trial registry record: https://www.irct.ir/trial/29983

Comparison of the effect of Ceratonia siliqua L. fruit oral capsule and vitamin E on semen parameters in men with idiopathic infertility: a triple-blind randomized controlled clinical trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Sima Sanagoo ◽  
Azizeh Farshbaf-Khalili ◽  
Parina Asgharian ◽  
Samad Hazhir ◽  
Behnaz Sadeghzadeh Oskouei
Keyword(s):  
Vitamin E ◽  
Sperm Motility ◽  
Sperm Count ◽  
Sperm Parameters ◽  
Semen Parameters ◽  
Controlled Clinical Trial ◽  
Ceratonia Siliqua ◽  
Randomized Controlled ◽  
Infertile Men ◽  
The Mean

Abstract Objectives To compare the effect of oral Ceratonia siliqua (Carob) and vitamin E on sperm parameters in idiopathic infertile men. Methods In this triple-blind randomized controlled trial study, fifty 20–45-year-old infertile men with idiopathic abnormal sperm parameters were selected among men referring to the infertility clinic of Al Zahra-Iran Hospital, and randomly allocated into two groups. The first group received Carob capsules, 500 mg, and the second group received vitamin E capsules three times a day for 90 days. The primary outcomes of this study were the sperm parameters (count, motility, and morphology). Results After the intervention, the mean of sperm count increased from 49.08 to 60.22 million/mL in the carob vs. it increased from 47.64 to 58.88 million/mL in the vitamin E group (adjusted mean difference (aMD)=1.124 million/ml, 95% CI: −12.892 to 15.141). The mean sperm motility increased from 45.90 to 52.90% in the carob group but decreased from 55.23 to 38.10% in the vitamin E group (aMD=17.22%, 95% CI: 8.53 to 25.92). The mean sperms with normal morphology increased from 11.52 to 67.05% in the carob, and from 10.20 to 77.47% in the vitamin E group (aMD=−10.88%, 95% CI: −22.30 to 0.536). There was no serious side effect during the treatment course. Conclusions Taking 1,500 mg oral dose of Carob capsule per day for 90 days improved sperm motility but had no significant effect for improving morphology and count comparing to vitamin E capsule.

scholarly journals Corrigendum to: “The effect of Phoenix dactylifera pollen on the expression of NRF2, SOD2, CAT, and GPX4 genes, and sperm parameters of fertile and infertile men: A controlled clinical trial” [Int J Reprod BioMed 2021; 19: 545-558]"

2021 ◽  
pp. 752
Author(s):  
Soghra Fallahi ◽  
Minoo Rajaei ◽  
Mohammad Javad Hesam ◽  
Mohsen Koolivand ◽  
Kianoosh Malekzadeh
Keyword(s):  
Clinical Trial ◽  
Phoenix Dactylifera ◽  
Sperm Parameters ◽  
Controlled Clinical Trial ◽  
Infertile Men

This article is a Corrigendum to: “The effect of Phoenix dactylifera pollen on the expression of NRF2, SOD2, CAT, and GPX4 genes, and sperm parameters of fertile and infertile men: A controlled clinical trial” [Int J Reprod BioMed 2021; 19: 545-558]". Please download the PDF or view the article HTML.

scholarly journals The effect of Phoenix dactylifera pollen on the expression of NRF2, SOD2, CAT, and GPX4 genes, and sperm parameters of fertile and infertile men: A controlled clinical trial

2021 ◽  
Author(s):  
Soghra Fallahi ◽  
Minoo Rajaei ◽  
Mohammad Javad Hesam ◽  
Mohsen Koolivand ◽  
Kianoosh Malekzadeh
Keyword(s):  
Clinical Trial ◽  
Male Infertility ◽  
Mrna Expression ◽  
Phoenix Dactylifera ◽  
Sperm Parameters ◽  
Controlled Clinical Trial ◽  
Antioxidant Genes ◽  
Expression Levels ◽  
Infertile Men ◽  
Mrna Expression Levels

Background: Oxidative stress is caused by the imbalance occurring between the creation and clearance of the reactive oxygen species (ROS), which is responsible for 30–40% of male infertility. The positive impact of phoenix dactylifera pollen (Date palm pollen, DPP) on the improvement of sperm parameters has been well documented in animal models. Objective: For evaluating the effect(s) of DPP on sperm parameters, ROS levels, expression of antioxidant genes, and activity of antioxidant enzymes of infertile men. Materials and Methods: In this controlled clinical trial, a total of 60 male case with infertility and 20 normospermic fertile men were recruited. Before and after the treatment with DPP, the case were administered 400 mg/kg of gelatinous capsules daily for 30 consecutive days and semen samples were taken. Quantitative real-time polymerase chain reaction was applied for the evaluation of the mRNA expression levels of Nuclear factor erythroid 2-related factor 2(NRF2), superoxide dismutase (SOD2), glutathione peroxidase 4(GPX4), and catalase (CAT) genes. Results: The mRNA expression levels of NRF2, SOD2, GPX4, and CAT (p < 0.05 for all) and significantly increased after treatment with DPP. The increased expressions of all antioxidant genes and enzymes significantly correlated with improvement in semen parameters including count (p = 0.01), motility (p = 0.05), and morphology (p = 0.01) of sperm. A significant correlation between the alteration of SOD2 gene expression and SOD activity, GPX4 and GPX, and CAT were also observed (p = 0.05). Conclusion: DPP can increase the expressions of NRF2, GPX4, SOD2, and CAT genes and also improve the semen quality in infertile men. Key words: DPP, Male infertility, SOD2, NRF2, GPX4, CAT, ROS, Spermatozoa.

scholarly journals Circulating sex hormone levels in relation to male sperm quality

2020 ◽  
Author(s):  
Wei Zhao ◽  
Jun Jing ◽  
Yong Shao ◽  
Rong Zeng ◽  
Cencen Wang ◽  
...  
Keyword(s):  
Sex Hormones ◽  
Sperm Motility ◽  
Sperm Quality ◽  
Sperm Count ◽  
Free Testosterone ◽  
Sex Hormone ◽  
Sperm Maturation ◽  
Sex Hormone Binding Globulin ◽  
Total Testosterone ◽  
Inverse Association

Abstract Background Although sex hormones play critical roles in spermatogenesis and sperm maturation, it remains inconclusive whether circulating sex hormones can serve as non-invasive biomarkers to improve the assessment of sperm quality. Methods We systematically evaluated the association of various sex hormones in serum with sperm quality among 338 men in subfertile couples. Concentrations of luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone (TT), total estradiol (E2), and sex hormone-binding globulin (SHBG) were detected by chemiluminescent immunoassay. Free testosterone and estradiol were calculated using a validated algorithm. A generalized liner regression model controlling for lifestyle factors was used to evaluate the associations with sperm count, concentration, motility, and morphology.Results After adjusting for age, body mass index, current smoking and alcohol drinking, LH, FSH, and TT levels were all inversely associated with sperm motility (all P for trend < 0.05); however, in mutual adjustment analysis, only LH remained an inverse association with sperm motility after adjusting for FSH and TT levels (P for trend = 0.04). Higher concentrations of LH were also associated with lower sperm progressive motility (P for trend = 0.04). Moreover, LH and FSH levels were both inversely associated with normal sperm morphology (P for trend = 0.04 and 0.02, respectively). Conclusions Increased levels of LH are associated with poor sperm motility and morphology, suggesting that LH may play a central role in sperm maturation. Future studies are warranted to assess potential clinical utility of LH for risk stratification and tailed prevention of male infertility.

scholarly journals Fixed Dose Combination Therapy of Antioxidants in Treatment of Idiopathic Oligoasthenozoospermia: Results of a Randomized, Double-blind, Placebo-controlled Clinical Trial

2013 ◽  
Vol 4 (1) ◽  
pp. 6-13 ◽  
Author(s):  
Sonia Malik ◽  
Sanjay Kalra ◽  
PM Gopinath ◽  
Ajit Saxena ◽  
Bharti Kalra ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Event ◽  
Combination Therapy ◽  
Sperm Motility ◽  
Sperm Count ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Dose Combination

ABSTRACT Introduction To assess the effectiveness and safety of fixed dose combination (FDC) of antioxidants in treatment of idiopathic oligoasthenozoospermia. Materials and methods Placebo-controlled, Double-blind, randomized, Parallel three arm, Multicentric trial. Setting Fertility clinics of five centers across India. Patients One hundred and thirty-eight male subjects, aged between 21 and 50 years and subfertile for 1 year or more with the following baseline sperm selection criteria: Concentration <15 million/ml and total sperm motility <40%. Intervention(s) Eligible subjects were randomized to either of the three arms in a double-blind manner, i.e. arm 1 was given 2 tablets twice daily of FDC of antioxidants (coenzyme-Q10: 50 mg, L-carnitine: 500 mg, lycopene: 2.5 mg and zinc: 12.5 mg); arm 2 was given 1 tablet of FDC of antioxidants and one tablet of placebo twice daily and arm 3 was two tablets twice daily of matching placebo all for 180 days. Main outcome measure(s) The primary outcome measures were improvement in sperm count and sperm motility, whereas pregnancy rate was the secondary efficacy outcome. Results Compared to placebo, a statistically significant improvement was seen in sperm count (14.8-26.35 in arm 1 and 14.37-24.8 million/ml in arm 2, p < 0.0001), and sperm total motility (39.2-51.6% in arm 1 and 38.4-50.1% in arm 2, p < 0.0001), at 90 days, and treatment further improved these parameters at day 180. No intergroup difference was seen between arm 1 and arm 2. Mild adverse event of upper gastrointestinal discomfort by 8 subjects (three in arm 1; one in arm 2 and four subjects in arm 3) were reported. No serious adverse event was seen in the study. Conclusion Exogenous administration of fixed dose combination of antioxidants is a safe and effective therapy in improving the male subfertility. How to cite this article Gopinath PM, Kalra B, Saxena A, Malik S, Kochhar K, Kalra S, Zaveri H. Fixed Dose Combination Therapy of Antioxidants in Treatment of Idiopathic Oligoasthenozoospermia: Results of a Randomized, Doubleblind, Placebo-controlled Clinical Trial. Int J Infertility Fetal Med 2013;4(1):6-13.

scholarly journals Circulating sex hormone levels in relation to male sperm quality

2019 ◽  
Author(s):  
Wei Zhao ◽  
Jun Jing ◽  
Yong Shao ◽  
Rong Zeng ◽  
Cencen Wang ◽  
...  
Keyword(s):  
Sex Hormones ◽  
Sperm Motility ◽  
Sperm Quality ◽  
Sperm Count ◽  
Sex Hormone ◽  
Sperm Maturation ◽  
Sex Hormone Binding Globulin ◽  
Total Testosterone ◽  
Inverse Association ◽  
Potential Biomarker

Abstract Background Although sex hormones play critical roles in spermatogenesis and sperm maturation, it remains inconclusive whether circulating sex hormones can serve as non-invasive biomarkers to determine sperm quality. Methods We systematically evaluated the association of various sex hormones in serum with sperm quality among 338 subfertile males. Concentrations of luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone (TT), total estradiol (E2), and sex hormone-binding globulin (SHBG) were detected by chemiluminescent immunoassay. Free testosterone and estradiol were calculated using a validated algorithm. A generalized liner regression model controlling for lifestyle factors was used to assess the associations with sperm count, concentration, motility, and morphology. Results After adjusting for age, body mass index, current smoking and alcohol drinking, LH, FSH, and TT levels were all inversely associated with sperm motility (all P for trend < 0.05); however, in mutual adjustment analysis, only LH remained an inverse association with sperm motility after adjusting for FSH and TT levels ( P for trend = 0.04 ). Higher concentrations of LH were also associated with lower sperm progressive motility ( P for trend = 0.04 ). Moreover, LH and FSH levels were both inversely associated with normal sperm morphology ( P for trend = 0.04 and 0.02, respectively ). Conclusions Increased levels of LH are associated with poor sperm motility and morphology. Our findings suggest that LH might play a central role in sperm maturation, which represents a potential biomarker to improve clinical evaluation of male infertility.

scholarly journals Does atorvastatin have augmentative effects with sodium valproate in prevention of migraine with aura attacks? A triple-blind controlled clinical trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Reza Ganji ◽  
Nastaran Majdinasab ◽  
Saeed Hesam ◽  
Nazanin Rostami ◽  
Mehdi Sayyah ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Sodium Valproate ◽  
Migraine With Aura ◽  
Vitamin D3 ◽  
Vascular Function ◽  
Intervention Group ◽  
Pain Severity ◽  
Controlled Clinical Trial ◽  
Prophylactic Regimen

Abstract Background Migraine is a painful and disabling nervous disorder which negatively affects the quality of life. Migraineurs may suffer from a generalized vasomotor dysfunction. Statins improve vasomotor and vascular function, with their pleiotropic effects. We aimed to assess efficacy and safety of adding Atorvastatin to prophylactic regimen in better control of migraine with aura. Methods This triple-blind controlled clinical trial was on 68 patients with migraine with aura. An interval of at least 1 month was given to evaluate vitamin D3 level and eligibility. In patients with vitamin D3 deficiency, the correction with vitamin D supplementation was provided. The patients were randomly assigned to receive atorvastatin 20 mg plus sodium valproate 500 mg or placebo plus sodium valproate 500 mg once a day for 2 months. The patients were evaluated based for the number of attacks and pain severity based on Visual Analogue Scale. Results There was a significant (p = 0.0001) improvement in severity of pain and number of migraine attacks by adding Atorvastin to the prophylactic regimen of patients with migraine with aura. After controlling for variable parameters, the differences between two arms of the study was yet statistically significant (p = 0.0001). A significant number of participants in intervention group were satisfied by their treatment (p = 0.001) with no remarkable side effects (P = 0.315). Conclusions Adding atorvastatin to migraine with aura preventive regimen may help reduce the number of acute attacks and pain severity without causing considerable side effects and led to a better patient satisfaction. Trial registration IRCT20180106038242N1. Registered: 7 February 2018.

scholarly journals “Include me if you can”—reasons for low enrollment of pediatric patients in a psychopharmacological trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Larissa Niemeyer ◽  
Konstantin Mechler ◽  
Jan Buitelaar ◽  
Sarah Durston ◽  
Bram Gooskens ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Demographic Data ◽  
Autism Spectrum ◽  
Current Therapy ◽  
Future Research ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Clinical Patient ◽  
Compulsive Disorder

Abstract Background Low recruitment in clinical trials is a common and costly problem which undermines medical research. This study aimed to investigate the challenges faced in recruiting children and adolescents with obsessive-compulsive disorder and autism spectrum disorder for a randomized, double-blind, placebo-controlled clinical trial and to analyze reasons for non-participation. The trial was part of the EU FP7 project TACTICS (Translational Adolescent and Childhood Therapeutic Interventions in Compulsive Syndromes). Methods Demographic data on pre-screening patients were collected systematically, including documented reasons for non-participation. Findings were grouped according to content, and descriptive statistical analyses of the data were performed. Results In total, n = 173 patients were pre-screened for potential participation in the clinical trial. Of these, only five (2.9%) were eventually enrolled. The main reasons for non-inclusion were as follows: failure to meet all inclusion criteria/meeting one or more of the exclusion criteria (n = 73; 42.2%), no interest in the trial or trials in general (n = 40; 23.1%), and not wanting changes to current therapy/medication (n = 14; 8.1%). Conclusions The findings from this study add valuable information to the existing knowledge on reasons for low clinical trial recruitment rates in pediatric psychiatric populations. Low enrollment and high exclusion rates raise the question of whether such selective study populations are representative of clinical patient cohorts. Consequently, the generalizability of the results of such trials may be limited. The present findings will be useful in the development of improved recruitment strategies and may guide future research in establishing the measurement of representativeness to ensure enhanced external validity in psychopharmacological clinical trials in pediatric populations. Trial registration EudraCT 2014-003080-38. Registered on 14 July 2014.

scholarly journals Effects of a Single Oral Megadose of Vitamin D3 on Inflammation and Oxidative Stress Markers in Overweight and Obese Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2021 ◽  
Vol Volume 14 ◽  
pp. 525-534
Author(s):  
Laine de Carvalho Guerra Pessoa Mamede ◽  
Rafaela Lira Formiga Cavalcanti de Lima ◽  
Alexandre Sérgio Silva ◽  
João Carlos Lima Rodrigues Pita ◽  
Nadjeanny Ingrid Galdino Gomes ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Clinical Trial ◽  
Vitamin D3 ◽  
Controlled Clinical Trial ◽  
Oxidative Stress Markers ◽  
Obese Women ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Stress Markers ◽  
And Oxidative Stress

scholarly journals From Spermiogram to Bio-Functional Sperm Parameters: When and Why Request Them?

2020 ◽  
Vol 9 (2) ◽  
pp. 406 ◽  
Author(s):  
Rosita A. Condorelli ◽  
Aldo E. Calogero ◽  
Giorgio I. Russo ◽  
Sandro La Vignera
Keyword(s):  
Normal Form ◽  
Sperm Motility ◽  
Sperm Count ◽  
Semen Analysis ◽  
Sperm Concentration ◽  
Sperm Parameters ◽  
Sperm Parameter ◽  
Progressive Motility ◽  
Semen Volume ◽  
Chromatin Compactness

The aim of this experimental study was to evaluate whether infertile patients may benefit from the evaluation of bio-functional sperm parameters in addition to the conventional semen analysis. To accomplish this, we evaluated the correlation between conventional and bio-functional sperm parameters based on their percentile distribution in search of a potential threshold of these latter that associates with conventional sperm parameter abnormalities. The study was conducted on 577 unselected patients with infertility lasting at least 12 months. We identified cut-off values according to the median of the population for mitochondrial membrane potential (MMP), number of alive spermatozoa, and chromatin abnormality. High MMP (HMMP) (≥46.25%) was associated with sperm concentration, sperm count, progressive motility, and normal form. Low MMP (LMMP) (≥36.5%) was found to be associated with semen volume, sperm concentration, total sperm count, progressive motility, total motility, and normal form. The number of alive spermatozoa (≥71.7%) was associated with sperm concentration and progressive motility whereas abnormal chromatin compactness (≥21.10%) was associated with sperm concentration, total sperm count, and progressive motility. The data would suggest that, for every increase in the percentile category of sperm concentration, the risk of finding an HMMP≤46.25 is reduced by 0.4 and by 0.66 for a total sperm count. This risk is also reduced by 0.60 for every increase in the percentile category of sperm progressive motility and by 0.71 for total sperm motility. Each increment of percentile category of the following sperm parameter was followed by a decrease in the risk of finding an LMMP≤36.5: sperm concentration 1.66, total sperm count 1.28, sperm progressive motility 1.27, total sperm motility 1.76, and normal form 1.73. Lastly, the data showed that, for every increase in the percentile category of total sperm count, the risk of finding an abnormal chromatin compactness ≤21.10 is reduced by 1.25 (1.04–1.51, p < 0.05) and an increase of total sperm motility is associated with a reduced risk by 1.44 (1.12–1.85, p < 0.05). Results suggest a correlation between bio-functional and conventional sperm parameters that impact the sperm fertilizing potential. Therefore, the evaluation of bio-functional sperm parameters by flow cytometry may be useful to explain some cases of idiopathic male infertility.

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