Hyperbaric Oxygen Therapy for Men Suffering From Infertility Due to Oligospermia.
ConditionOligospermia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age21+
SponsorAssaf-Harofeh Medical Center
About this trial
Infertility in a couple is defined as the inability to achieve conception despite one year of frequent, unprotected intercourse. Infertility affects approximately 12% of couples attempting to conceive. The goal of this study is to explore the potential beneficial effect of HBOT on sperm count of infertile male due to oligospermia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age above 21 years
At least two sperm examination showing oligospermia (<15·106 sperm/mL)
Diagnosis of idiopathic oligospermia.
Subject willing and able to read, understand and sign an informed consent
Disqualifiers
Inability to attend scheduled clinic visits and/or comply with the study protocol
Active malignancy
Previous treatment with chemotherapy and/or radiation therapy
Substance use at baseline
Trial design
Design model
Single group
Treatments tested in this trial
Hyperbaric oxygen therapy
DeviceEach session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Hyperbaric Oxygen Therapy active armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sperm count
Change from baseline in sperm count measured by Sperm Analysis
Time frame
At baseline, 3 monthsSecondary outcomes
1
Sperm morphology
Change from baseline in sperm morphology measured by Sperm Analysis
Time frame
At baseline, 3 months, 9 months2
Sperm count
Change from baseline in sperm count measured by Sperm Analysis
Time frame
9 months3
Sperm motility
Change from baseline in sperm motility measured by Sperm Analysis
Time frame
At baseline, 3 months, 9 months4
Sperm telomeres length
Change from baseline in sperm telomeres length
Time frame
At baseline, 3 months, 9 monthsOther outcomes
1
Change from baseline of anaerobic threshold by cardio-pulmonary exercise testing CPET
CPET determines the anaerobic threshold that is expected to change through the intervention
Time frame
At baseline, 3 monthsSponsors and contacts
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Source ClinicalTrials.gov