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

Primary Purpose

Oligospermia

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hyperbaric oxygen therapy
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oligospermia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperbaric Oxygen Therapy active arm

Arm Description

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

Outcomes

Primary Outcome Measures

Sperm count
Change from baseline in sperm count measured by Sperm Analysis

Secondary Outcome Measures

Sperm morphology
Change from baseline in sperm morphology measured by Sperm Analysis
Sperm count
Change from baseline in sperm count measured by Sperm Analysis
Sperm motility
Change from baseline in sperm motility measured by Sperm Analysis
Sperm telomeres length
Change from baseline in sperm telomeres length
Lymphocyte telomeres length
Change from baseline of lymphocyte telomeres length

Full Information

First Posted
April 24, 2023
Last Updated
July 25, 2023
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05842239
Brief Title
Hyperbaric Oxygen Therapy for Men Suffering From Infertility Due to Oligospermia.
Official Title
Hyperbaric Oxygen Therapy for Men Suffering From Infertility Due to Oligospermia: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligospermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric Oxygen Therapy active arm
Arm Type
Experimental
Arm Description
The protocol comprises of 60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period.
Intervention Type
Device
Intervention Name(s)
Hyperbaric oxygen therapy
Intervention Description
Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Primary Outcome Measure Information:
Title
Sperm count
Description
Change from baseline in sperm count measured by Sperm Analysis
Time Frame
At baseline, 3 months
Secondary Outcome Measure Information:
Title
Sperm morphology
Description
Change from baseline in sperm morphology measured by Sperm Analysis
Time Frame
At baseline, 3 months, 9 months
Title
Sperm count
Description
Change from baseline in sperm count measured by Sperm Analysis
Time Frame
9 months
Title
Sperm motility
Description
Change from baseline in sperm motility measured by Sperm Analysis
Time Frame
At baseline, 3 months, 9 months
Title
Sperm telomeres length
Description
Change from baseline in sperm telomeres length
Time Frame
At baseline, 3 months, 9 months
Title
Lymphocyte telomeres length
Description
Change from baseline of lymphocyte telomeres length
Time Frame
At baseline, 3 months, 9 months
Other Pre-specified Outcome Measures:
Title
Change from baseline of anaerobic threshold by cardio-pulmonary exercise testing CPET
Description
CPET determines the anaerobic threshold that is expected to change through the intervention
Time Frame
At baseline, 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shachar Finci, MD
Phone
97289542395
Email
shacharf@shamir.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Shai a Efrati, MD
Phone
972549212866
Email
efratishai@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shachar Finci, MD
Organizational Affiliation
Asaf-Harofhe MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shachar Finci, MD
Phone
972-8-9779393
Email
shacharf@shamir.gov.il

12. IPD Sharing Statement

Learn more about this trial

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

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