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Clinical Trials/CTRI/2024/06/068939
CTRI/2024/06/068939
Not yet recruiting
未知

A Prospective Interventional Open label Single-centre Single arm Study to Evaluate the Efficacy and Safety of CoQ10 Capsules in Subject suffering with Oligospermia - NI

M/s Synthite Industries Private Limited0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: N461- Oligospermia
Sponsor
M/s Synthite Industries Private Limited
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
M/s Synthite Industries Private Limited

Eligibility Criteria

Inclusion Criteria

  • 1 Male participants aged 18 to 50 years
  • 2 Diagnosis of oligospermia, confirmed by semen analysis showing a sperm concentration of less than 15 million sperm per milliliter or through medical history of the subjects
  • 3 Willingness to provide informed consent to participate in the study
  • 4 Ability to comply with the study protocol including attending study visits and completing study\-related assessments.
  • 5 Stable sexual partner or intention to engage in heterosexual intercourse for the duration of the study
  • 6 Willingness to refrain from using other fertility treatments or supplements during the study period
  • 7 Adequate understanding of the study procedures and willingness to follow the investigators instructions

Exclusion Criteria

  • 1\. History and drug alcohol abuse smoking
  • 2\. BMI greater than 30 kg per m2
  • 3\. History of cancer chemotherapy
  • 4\. History of significant medical conditions that could affect fertility or interfere with study participation including severe cardiovascular disease uncontrolled hypertension renal failure liver disease or malignancy
  • 5\. Contraindication for the use of CoQ10
  • 6\. Genital disease (cryptorchidism current genital inflammation or varicocele)
  • 7\. Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related illness and or known history of Hepatitis B virus (HBV) defined by presence of hepatitis B surface antigen (HBsAg) and or known history of Hepatitis C virus (HCV) defined by presence of hepatitis C antibody (HCVAb)
  • 8\. Genital trauma or surgery to the reproductive system
  • 9\. Hepatobiliary disease
  • 10\. Significant renal insufficiency

Outcomes

Primary Outcomes

Not specified

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