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NCT Number: NCT05842239

Hyperbaric Oxygen Therapy for Men Suffering From Infertility 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 goal of this study is to explore the potential beneficial effect of HBOT on sperm count of infertile male due to oligospermia.

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Key information

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)

Ẕerifin, 70300, Israel

Location status: Recruiting

Location contact

Shachar Finci, MD

CONTACT

[email protected]

972-8-9779393

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Severe or unstable physical disorders or major cognitive deficits at baseline
  • HBOT for any reason prior to study enrolment
  • Chest pathology incompatible with pressure changes (including moderate to severe asthma)
  • Ear or Sinus pathology incompatible with pressure changes
  • Chronic disease like diabetes mellitus, ischemic heart disease etc.
  • Active smoking

Treatment and study plan

hyperbaric oxygen therapy

Device

Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes

Primary outcomes

  1. Sperm count

    Time frame: At baseline, 3 months

    Change from baseline in sperm count measured by Sperm Analysis

Secondary outcomes

  1. Sperm morphology

    Time frame: At baseline, 3 months, 9 months

    Change from baseline in sperm morphology measured by Sperm Analysis

  2. Sperm count

    Time frame: 9 months

    Change from baseline in sperm count measured by Sperm Analysis

  3. Sperm motility

    Time frame: At baseline, 3 months, 9 months

    Change from baseline in sperm motility measured by Sperm Analysis

  4. Sperm telomeres length

    Time frame: At baseline, 3 months, 9 months

    Change from baseline in sperm telomeres length

  5. Lymphocyte telomeres length

    Time frame: At baseline, 3 months, 9 months

    Change from baseline of lymphocyte telomeres length

Other outcomes

  1. Change from baseline of anaerobic threshold by cardio-pulmonary exercise testing CPET

    Time frame: At baseline, 3 months

    CPET determines the anaerobic threshold that is expected to change through the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Shachar Finci, MD

CONTACT

[email protected]

97289542395

Shai a Efrati, MD

CONTACT

[email protected]

972549212866

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
May 6, 2023
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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