Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures (Astax-ART)
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|ClinicalTrials.gov Identifier: NCT02310087|
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Male||Dietary Supplement: astaxanthin with vitamin E Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Eighty infertile men with OAT were randomly assigned to receive either daily 16 mg of astaxanthin and 40 mg of vitamin E in capsules or placebo. At baseline and after three months of treatment semen quality was assessed according to the WHO guidelines. The sperm concentration, motility and morphology were determined by standard microscopic analyses. Sperm DNA fragmentation was evaluated using a TUNEL assay . Mitochondrial membrane potential was measured by means of 3,3'-dihexyloxacarbocyanine iodide (DiOC6) staining as an indicator of mitochondrial membrane integrity and the mitochondrial potential capacity to generate ATP by oxidative phosphorylation. The serum level of FSH was measured by a solid-phase, two-site chemiluminescent immunometric assay.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||no other masking|
|Official Title:||Effect of Oral Administration of Astaxanthin on Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||January 2019|
Active Comparator: astaxanthin with vitamin E
The participants in the study group will be given perorally four tablets of 4 mg astaxanthin with 10 mg vitamin E (Astasan, Sensilab, Slovenia) daily, taken in single daily dose. The total daily dose will be 16 mg astaxanthin with 40 mg vitamin E. The product will be taken for three months continuously.
Dietary Supplement: astaxanthin with vitamin E
Four tablets of 4 mg astaxanthin with 10 mg vitamin E daily, taken at once. Daily dose is 16 mg astaxanthin with 40 mg vitamin E. Continuously for three months.
Other Name: Astasan, Sensilab, Slovenia
Placebo Comparator: placebo
The participants in the control group will be given perorally four tablets of placebo daily taken in single daily dose. The placebo tablets are of the same size and colour as the study tablets and were produced by manufacturer of Astasan, Sensilab, Slovenia. The placebo will be taken for three months continuously.
Four tablets of placebo daily, taken at once. Continuously for three months.
- semen quality [ Time Frame: three months ]In semen quality the spermiogram, DNA fragmentation and mitochondrial membrane potential before and after the intervention will be evaluated. The DNA fragmentation will be evaluated by terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate (dUTP)-biotin nick end labeling (TUNEL) method, and mitochondrial membrane potential with carbocyanine fluorochrome DiOC6.
- follicle stimulating hormone (FSH) [ Time Frame: three months ]FSH levels in before and after the intervention will be evaluated in infertile men with oligoasthenozoospermia.
- fertilization and embryo development in Assisted Reproduction Techniques (ART) [ Time Frame: six months ]Fertilization rates and the quality of embryo development on day 3 in ICSI procedure in infertile couples will be determined after the three months of dietary supplementation of astaxanthin with vitamin E taken by infertile men with oligoasthenozoospermia.
- pregnancy rates and miscarriage rates in 1st trimester after ART [ Time Frame: nine months ]Pregnancy rates and miscarriage rates in 1st trimester after ART will be determined after the three months of dietary supplementation of astaxanthin with vitamin E taken by infertile men with oligoasthenozoospermia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310087
|Division of Ob/Gyn, University Medical Centre Ljubljana|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||Bojana Pinter, MD, PhD||Division of Ob/Gyn, University Medical Centre Ljubljana, Slovenia|