An interventional study of Hyperbaric oxygen therapy in Oligospermia, sponsored by Assaf-Harofeh Medical Center. Recruiting at 1 site in Israel. Open to male participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment
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.
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 male factor is equally attribute to couple infertility like woman infertility.
Male infertil¬ity may have many reasons. In up to 90% of male infertility cases, there is a decrease in sperm count or the might show poor sperm quality. During spermatogenesis, mitochondria undergo continuous morphological and distributional changes with germ cell development. Deficiencies in these processes lead to mitochondrial dysfunction and abnormal spermatogenesis, thereby causing male infertility.
In addition to mitochondria, telomer also play a significant role in sperm functionality. Telomere length is considered one of the most relevant biological markers of genomic stability. The negative impact of telomere shortening on sperm quality has been suggested as an important indicator of male infertility.
It is now understood that Hyperbaric oxygen treatment (HBOT), triggers both oxygen and pressure sensitive genes, resulting in inducing mitochondrial proliferation, increase in complex I activity and those mitochondrial efficiency. With respect to telomers, in a recent study, it was demonstrated that HBOT can induce telomeres elongation.
The goal of this study is to explore the potential beneficial effect of HBOT on sperm count of infertile male due to oligospermia.
All eligible participants will receive hyperbaric treatment. The treatment will be administrated in a multi-place chamber. The protocol comprises of 60 daily sessions, 5 sessions per week within a three-month period. Each session includes breathing 100% oxygen by mask at 2ATA for 90 minutes with 5-minute air breaks every 20 minutes.
The evaluation procedure will be performed 4 times, at baseline, after 40 sessions, end of the treatment period and 60 days after the treatment ended, and includes sperm analysis, sperm and lymphocyt telomeres length.
64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.
This study's planned enrollment of 15 is below the median of 65 across 46 interventional studies indexed under Oligospermia.
Browse Oligospermia studies →Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protocol comprises of 60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period.
Device: Hyperbaric oxygen therapy
Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Sperm count
Change from baseline in sperm count measured by Sperm Analysis
Time frame: At baseline, 3 months
Sperm morphology
Change from baseline in sperm morphology measured by Sperm Analysis
Time frame: At baseline, 3 months, 9 months
Sperm count
Change from baseline in sperm count measured by Sperm Analysis
Time frame: 9 months
Sperm motility
Change from baseline in sperm motility measured by Sperm Analysis
Time frame: At baseline, 3 months, 9 months
Sperm telomeres length
Change from baseline in sperm telomeres length
Time frame: At baseline, 3 months, 9 months
Lymphocyte telomeres length
Change from baseline of lymphocyte telomeres length
Time frame: At baseline, 3 months, 9 months
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 months
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