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

Oligospermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842239
• Other study ID #: 209-22-ASF
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2023
• Source: Assaf-Harofeh Medical Center
• Contact: Shachar Finci, MD
• Phone: 97289542395
• Email: shacharf[@]shamir.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Oligospermia

Intervention

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

Locations

Country	Name	City	State
Israel	The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Sperm count	Change from baseline in sperm count measured by Sperm Analysis	At baseline, 3 months
Secondary	Sperm morphology	Change from baseline in sperm morphology measured by Sperm Analysis	At baseline, 3 months, 9 months
Secondary	Sperm count	Change from baseline in sperm count measured by Sperm Analysis	9 months
Secondary	Sperm motility	Change from baseline in sperm motility measured by Sperm Analysis	At baseline, 3 months, 9 months
Secondary	Sperm telomeres length	Change from baseline in sperm telomeres length	At baseline, 3 months, 9 months
Secondary	Lymphocyte telomeres length	Change from baseline of lymphocyte telomeres length	At baseline, 3 months, 9 months