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

University Medical Centre Ljubljana

Status: Completed

Conditions: Infertility, Male

Treatments: Other: Placebo; Dietary Supplement: astaxanthin with vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT02310087

UMCLjubljana-20140041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

astaxanthin with vitamin E

Active Comparator group

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.

Treatment:

Dietary Supplement: astaxanthin with vitamin E

placebo

Placebo Comparator group

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.

Treatment:

Other: Placebo