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

Not Applicable

Completed

• Conditions: Infertility, Male
• Interventions: Dietary Supplement: astaxanthin with vitamin E; Other: Placebo

• Registration Number: NCT02310087
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-05
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
astaxanthin with vitamin E	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.
placebo	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.

Primary Outcome Measures

Name	Time	Method
semen quality	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

Name	Time	Method
pregnancy rates and miscarriage rates in 1st trimester after ART	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.
follicle stimulating hormone (FSH)	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)	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.

Trial Locations

Locations (1)

Division of Ob/Gyn, University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia