NCT05842239

Hyperbaric Oxygen Therapy for Men Suffering From Infertility Due to Oligospermia.

Hyperbaric Oxygen Therapy for Men Suffering From Infertility Due to Oligospermia: a Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Oligospermia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-20
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-05-06
• Last updated: 2024-07-03

Locations

1 site across 1 country: Israel