Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures (Astax-ART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02310087
Recruitment Status : Recruiting
First Posted : December 5, 2014
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Bojana Pinter, University Medical Centre Ljubljana

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infertility, Male Dietary Supplement: astaxanthin with vitamin E Other: Placebo Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Oral Administration of Astaxanthin on Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures
Study Start Date : November 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
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.
Other: Placebo
Four tablets of placebo daily, taken at once. Continuously for three months.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Bojana Pinter, MD, PhD +386-41-718-923 bojana.pinter@kclj.si
Contact: Senka Imamovic Kumalic, MD +386-40-614-904 senka81@gmail.com

Locations
Layout table for location information
Slovenia
Division of Ob/Gyn, University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Bojana Pinter, MD, PhD    +386-41-718-923    bojana.pinter@kclj.si   
Contact: Senka Imamovic Kumalic, MD    +386-40-614-904    senka81@gmail.com   
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Layout table for investigator information
Principal Investigator: Bojana Pinter, MD, PhD Division of Ob/Gyn, University Medical Centre Ljubljana, Slovenia

Publications:

Layout table for additonal information
Responsible Party: Bojana Pinter, Assoc. Prof., MD, PhD, Spec in Ob/Gyn, MS (Econ), University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02310087     History of Changes
Other Study ID Numbers: UMCLjubljana-20140041
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Bojana Pinter, University Medical Centre Ljubljana:
male infertility
spermatogenesis
antioxidants
DNA damage
mitochondrial membrane potential
apoptosis

Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents