Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05842239
Other study ID # 209-22-ASF
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05506722 - Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity N/A
Recruiting NCT04795440 - Comparison of ICSI Outcomes in Cycles Using Testicular and Ejaculate Sperm From Couples With High SDF N/A
Completed NCT03898752 - Is Oxidative Stress in Semen Reduced by Lifestyle Intervention N/A
Recruiting NCT02063256 - 7 NUTS Study. Diet Modification and Male Fertility. Phase 2/Phase 3
Active, not recruiting NCT05134428 - Safety Evaluation of the ADAM System N/A
Not yet recruiting NCT06260007 - Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia Phase 4
Terminated NCT00440180 - Aromatase Inhibitors in the Treatment of Male Infertility Phase 3
Completed NCT01409837 - The Effect and Safety of Lisinopril in Non-hypertensive Men With Infertility From Low Sperm Count Phase 2
Completed NCT01239186 - Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men N/A
Not yet recruiting NCT00479960 - A Preliminary Study on Effect of Omega-3 on Human Sperm Phase 0
Recruiting NCT06342856 - Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia Early Phase 1
Recruiting NCT01856361 - Ramipril for the Treatment of Oligospermia N/A
Not yet recruiting NCT01520584 - Supplement Intake in Infertile Men;the Effect on Sperm Parameters,Fertilization Rate and Embryo Quality N/A
Completed NCT01509482 - Insulin Resistance in Idiopathic Oligospermia and Azoospermia N/A
Completed NCT00548977 - Genetic Studies Spermatogenic Failure N/A
Completed NCT04349345 - Seminal Fluid's Changes Over 20 Years
Recruiting NCT05320536 - A Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia, Asthenia, and Teratozoospermia Phase 4
Recruiting NCT05158114 - Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Testicular Injury and Oligospermia Phase 1
Completed NCT02234206 - A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count Phase 2
Recruiting NCT06202469 - Creatine and Ubiquinol for Sperm Quality N/A