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Clinical Trial NCT05842239 for Oligospermia is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Hyperbaric Oxygen Therapy for Men Suffering From Infertility Due to Oligospermia. 15

Recruiting
Clinical Trial NCT05842239 is an interventional study for Oligospermia that is recruiting. It started on 20 January 2024 with plans to enroll 15 participants. Led by Assaf-Harofeh Medical Center, it is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 3 July 2024.
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 ...

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Official Title

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

Conditions
Oligospermia
Other Study IDs
  • 209-22-ASF
NCT ID Number
NCT05842239
Start Date (Actual)
2024-01-20
Last Update Posted
2024-07-03
Completion Date (Estimated)
2025-12-01
Enrollment (Estimated)
15
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalHyperbaric Oxygen Therapy active arm
The protocol comprises of 60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period.
Hyperbaric oxygen therapy
Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Sperm count
Change from baseline in sperm count measured by Sperm Analysis
At baseline, 3 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Sperm morphology
Change from baseline in sperm morphology measured by Sperm Analysis
At baseline, 3 months, 9 months
Sperm count
Change from baseline in sperm count measured by Sperm Analysis
9 months
Sperm motility
Change from baseline in sperm motility measured by Sperm Analysis
At baseline, 3 months, 9 months
Sperm telomeres length
Change from baseline in sperm telomeres length
At baseline, 3 months, 9 months
Lymphocyte telomeres length
Change from baseline of lymphocyte telomeres length
At baseline, 3 months, 9 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
21 Years
Eligible Sexes
Male
Accepts Healthy Volunteers
Yes
  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

  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
Assaf-Harofeh Medical Center logoAssaf-Harofeh Medical Center
Study Central Contact
Contact: Shachar Finci, MD, 97289542395, [email protected]
Contact: Shai a Efrati, MD, 972549212866, [email protected]
1 Study Locations in 1 Countries
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh), Ẕerifin, 70300, Israel
Shachar Finci, MD, Contact, 972-8-9779393, [email protected]
Recruiting