Clinical trial NCT05842239: 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
Overall status: RECRUITING
Phase: NA
Conditions: Oligospermia
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-05-06
Enrollment: 15
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sperm count
timeFrame: At baseline, 3 months
Secondary outcomes:
measure: Sperm morphology
timeFrame: At baseline, 3 months, 9 months
measure: Sperm count
timeFrame: 9 months
measure: Sperm motility
timeFrame: At baseline, 3 months, 9 months
measure: Sperm telomeres length
timeFrame: At baseline, 3 months, 9 months
measure: Lymphocyte telomeres length
timeFrame: At baseline, 3 months, 9 months
Other outcomes:
measure: Change from baseline of anaerobic threshold by cardio-pulmonary exercise testing CPET
timeFrame: At baseline, 3 months
Locations:
city: Zerifin
country: Israel
facility: The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Study officials:
affiliation: Asaf-Harofhe MC
name: Shachar Finci, MD
role: PRINCIPAL_INVESTIGATOR
References: