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

Primary Purpose

Infertility, Male

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
astaxanthin with vitamin E
Placebo
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male focused on measuring male infertility, spermatogenesis, antioxidants, DNA damage, mitochondrial membrane potential, apoptosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Ob/Gyn, University Medical Centre Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

astaxanthin with vitamin E

placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

semen quality
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

follicle stimulating hormone (FSH)
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)
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
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.

Full Information

First Posted
December 3, 2014
Last Updated
March 28, 2019
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT02310087
Brief Title
Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures
Acronym
Astax-ART
Official Title
Effect of Oral Administration of Astaxanthin on Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
Keywords
male infertility, spermatogenesis, antioxidants, DNA damage, mitochondrial membrane potential, apoptosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
no other masking
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
astaxanthin with vitamin E
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
astaxanthin with vitamin E
Other Intervention Name(s)
Astasan, Sensilab, Slovenia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Four tablets of placebo daily, taken at once. Continuously for three months.
Primary Outcome Measure Information:
Title
semen quality
Description
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.
Time Frame
three months
Secondary Outcome Measure Information:
Title
follicle stimulating hormone (FSH)
Description
FSH levels in before and after the intervention will be evaluated in infertile men with oligoasthenozoospermia.
Time Frame
three months
Title
fertilization and embryo development in Assisted Reproduction Techniques (ART)
Description
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.
Time Frame
six months
Title
pregnancy rates and miscarriage rates in 1st trimester after ART
Description
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.
Time Frame
nine months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bojana Pinter, MD, PhD
Organizational Affiliation
Division of Ob/Gyn, University Medical Centre Ljubljana, Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Ob/Gyn, University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The datasets generated and analysed during the current study could not be publicly available because they are in the Slovene language. Unauthorised translation may lead to data misunderstanding or misinterpretation.
Citations:
PubMed Identifier
24800224
Citation
Imamovic Kumalic S, Pinter B. Review of clinical trials on effects of oral antioxidants on basic semen and other parameters in idiopathic oligoasthenoteratozoospermia. Biomed Res Int. 2014;2014:426951. doi: 10.1155/2014/426951. Epub 2014 Mar 31.
Results Reference
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PubMed Identifier
21207519
Citation
Yuan JP, Peng J, Yin K, Wang JH. Potential health-promoting effects of astaxanthin: a high-value carotenoid mostly from microalgae. Mol Nutr Food Res. 2011 Jan;55(1):150-65. doi: 10.1002/mnfr.201000414. Epub 2010 Nov 18.
Results Reference
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PubMed Identifier
15169573
Citation
Agarwal A, Nallella KP, Allamaneni SS, Said TM. Role of antioxidants in treatment of male infertility: an overview of the literature. Reprod Biomed Online. 2004 Jun;8(6):616-27. doi: 10.1016/s1472-6483(10)61641-0.
Results Reference
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PubMed Identifier
16431409
Citation
Higuera-Ciapara I, Felix-Valenzuela L, Goycoolea FM. Astaxanthin: a review of its chemistry and applications. Crit Rev Food Sci Nutr. 2006;46(2):185-96. doi: 10.1080/10408690590957188.
Results Reference
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PubMed Identifier
16110353
Citation
Comhaire FH, El Garem Y, Mahmoud A, Eertmans F, Schoonjans F. Combined conventional/antioxidant "Astaxanthin" treatment for male infertility: a double blind, randomized trial. Asian J Androl. 2005 Sep;7(3):257-62. doi: 10.1111/j.1745-7262.2005.00047.x.
Results Reference
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PubMed Identifier
18616888
Citation
Franco JG Jr, Baruffi RL, Mauri AL, Petersen CG, Oliveira JB, Vagnini L. Significance of large nuclear vacuoles in human spermatozoa: implications for ICSI. Reprod Biomed Online. 2008 Jul;17(1):42-5. doi: 10.1016/s1472-6483(10)60291-x.
Results Reference
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PubMed Identifier
14640375
Citation
Chemes EH, Rawe YV. Sperm pathology: a step beyond descriptive morphology. Origin, characterization and fertility potential of abnormal sperm phenotypes in infertile men. Hum Reprod Update. 2003 Sep-Oct;9(5):405-28. doi: 10.1093/humupd/dmg034.
Results Reference
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PubMed Identifier
15136092
Citation
Virro MR, Larson-Cook KL, Evenson DP. Sperm chromatin structure assay (SCSA) parameters are related to fertilization, blastocyst development, and ongoing pregnancy in in vitro fertilization and intracytoplasmic sperm injection cycles. Fertil Steril. 2004 May;81(5):1289-95. doi: 10.1016/j.fertnstert.2003.09.063.
Results Reference
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PubMed Identifier
11980749
Citation
Marchetti C, Obert G, Deffosez A, Formstecher P, Marchetti P. Study of mitochondrial membrane potential, reactive oxygen species, DNA fragmentation and cell viability by flow cytometry in human sperm. Hum Reprod. 2002 May;17(5):1257-65. doi: 10.1093/humrep/17.5.1257.
Results Reference
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Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures

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