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

NCT05842239 | Recruiting

• 1 other identifier: 0209-22-ASF
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oligospermia

Outcome Measures

Primary Outcomes (1)

• Sperm count

  Change from baseline in sperm count measured by Sperm Analysis

  At baseline, 3 months

Secondary Outcomes (5)

• Sperm morphology

  At baseline, 3 months, 9 months

• Sperm count

  9 months

• Sperm motility

  At baseline, 3 months, 9 months

• Sperm telomeres length

  At baseline, 3 months, 9 months

• Lymphocyte telomeres length

  At baseline, 3 months, 9 months

Other Outcomes (1)

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

  At baseline, 3 months

Study Arms (1)

Hyperbaric Oxygen Therapy active arm

EXPERIMENTAL

The protocol comprises of 60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period.

Device: Hyperbaric oxygen therapy

Interventions

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

Hyperbaric Oxygen Therapy active arm

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

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

Ẕerifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Oligospermia

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Shachar Finci, MD

  Asaf-Harofhe MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shachar Finci, MD

CONTACT

97289542395; shacharf@shamir.gov.il

Shai a Efrati, MD

CONTACT

972549212866; efratishai@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: January 20, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

IL (1)