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

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.

Study Overview

• Status: Recruiting
• Conditions: Oligospermia
• Intervention / Treatment: Device: Hyperbaric oxygen therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shai a Efrati, MD; Phone Number: 972549212866; Email: efratishai@outlook.com
• Study Contact Backup: Name: Shachar Finci, MD; Phone Number: 97289542395; Email: shacharf@shamir.gov.il

Study Locations

• Israel
  • Ẕerifin, Israel, 70300
    • Recruiting
    • The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
    • Contact: Shachar Finci, MD; Phone Number: 972-8-9779393; Email: shacharf@shamir.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age above 21 years
2. At least two sperm examination showing oligospermia (<15·106 sperm/mL)
3. Diagnosis of idiopathic oligospermia.
4. Subject willing and able to read, understand and sign an informed consent

Exclusion Criteria:

1. Inability to attend scheduled clinic visits and/or comply with the study protocol
2. Active malignancy
3. Previous treatment with chemotherapy and/or radiation therapy
4. Substance use at baseline
5. Severe or unstable physical disorders or major cognitive deficits at baseline
6. HBOT for any reason prior to study enrolment
7. Chest pathology incompatible with pressure changes (including moderate to severe asthma)
8. Ear or Sinus pathology incompatible with pressure changes
9. Chronic disease like diabetes mellitus, ischemic heart disease etc.
10. Active smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperbaric Oxygen Therapy active arm; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm count	Change from baseline in sperm count measured by Sperm Analysis	At baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm morphology	Change from baseline in sperm morphology measured by Sperm Analysis	At baseline, 3 months, 9 months
Sperm count	Change from baseline in sperm count measured by Sperm Analysis	9 months
Sperm motility	Change from baseline in sperm motility measured by Sperm Analysis	At baseline, 3 months, 9 months
Sperm telomeres length	Change from baseline in sperm telomeres length	At baseline, 3 months, 9 months
Lymphocyte telomeres length	Change from baseline of lymphocyte telomeres length	At baseline, 3 months, 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline, 3 months

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Shachar Finci, MD, Asaf-Harofhe MC

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Infertility, Male; Infertility; Oligospermia; Therapeutics; Respiratory Therapy; Oxygen Inhalation Therapy; Hyperbaric Oxygenation
• Other Study ID Numbers: 0209-22-ASF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No