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Completed

NCT Number: NCT02310087

Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures

The purpose of the study is to determine whether administration of dietary supplement of astaxanthin with vitamin E improves the quality of sperm, fertilization and embryo development in Assisted Reproduction Techniques (ART) procedures.

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Key information

Conditions

Infertility, Male Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Division of Ob/Gyn, University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

In the study male patients diagnosed with oligoasthenozoospermia - with an abnormal sperm concentration and motility, irrespective of the morphology of spermatozoa - treated with their female partner with assisted reproduction techniques (ISCI) will be included. In the double blind study male patients will be given astaxanthin with vitamin E (study group, 40 patients) or placebo (control group, 40 patients) for three months prior to ART. In the study and the control group the quality of sperm (spermiogram), DNA fragmentation and mitochondrial membrane potential of semen before and after the dietary supplementation will be evaluated. In the ART procedure (ICSI) the fertilization rate, the quality of embryos, pregnancy rates and miscarriages rates in 1st trimester will be compared between the study and control group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • oligoasthenozoospermia with of without teratozoospermia by WHO criteria from the year 2010
  • fresh semen
  • female partner younger than 38 years
  • idiopathic or tubal infertility in female partners
  • at least 4 oocytes retrieved in previous ovarian punction in ART cycle, if previously performed
  • 1st, 2nd or 3rd cycle of ART

Exclusion criteria

  • genetic indication for ART procedure
  • donated semen
  • polycystic ovary syndrome in female partner
  • dietary supplementation intake of antioxidants (selenium, zink, vitamin E, vitamin C, vitamin A) in male participant in the last three months
  • smoking in male participant >20 cigarettes per day

Treatment and study plan

astaxanthin with vitamin E

Dietary Supplement

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 names: Astasan, Sensilab, Slovenia

Placebo

Other

Four tablets of placebo daily, taken at once. Continuously for three months.

Primary outcomes

  1. 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.

Secondary outcomes

  1. follicle stimulating hormone (FSH)

    Time frame: three months

    FSH levels in before and after the intervention will be evaluated in infertile men with oligoasthenozoospermia.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Effect of Oral Administration of Astaxanthin on Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures

Acronym: Astax-ART

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2014
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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