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Oxidative Stress In Semen And Male Infertility

Primary Purpose

Antioxidants, Infertility, Male, Semen Quality

Status

Unknown status

Phase

Phase 4

Locations

Qatar

Study Type

Interventional

Intervention

Fairhaven Pro for men

Semen analysis

Sperm DNA fragmentation

Static Oxidation reduction potential in semen

About this trial

This is an interventional treatment trial for Antioxidants focused on measuring semen, male infertility, semen quality, sperm DNA fragmentation, oxidation reduction potential

Eligibility Criteria

20 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Abnormal sperm parameters defined as having at least two out of the following three criteria:
Sperm Concentration > 1 and ≤ 15 million per ml
Sperm total Motility ≤ 40%
Sperm Morphology by Strict Criteria; normal forms ≤ 4.0%
Absence of infection in semen (pus cells < 1 X 106/ml)
No history of taking any therapy for their infertility including OTC treatment and vitamin supplementation
No history of obstructive azoospermia
No history of testicular cancer

Exclusion Criteria:

Semen volume ≤ 1.5 mL
Hydrocele, clinical varicocele (grade 2 and higher), orchitis, epididymitis, Cryptorchidism, irradiation or subjects that received chemotherapy treatment
Clinically meaningful endocrinopathy defined as an endocrinopathy which requires endocrine medications (e.g. Diabetes, Thyroid disease, Pituitary diseases, Adrenal diseases, etc.) or measurement of the following hormonal values:
1. Testosterone < 10.4 nmol/L
2. LH <1 or > 9 IU/L and or FSH <1 or >19 IU/mL
3. Elevated prolactin >407 mIU/L
4. Elevated TSH > 4.5 U/mL
5. Elevated Estrogen> 275 pmol/L
Leukocytospermia: WBC count of > 1 X 106/ ml
Known HIV infection
Use of antioxidant agents or vitamins within 8 weeks prior to inclusion into the study
Consumption of more than 1 unit of alcohol daily*
Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc.
History of current use of illegal or "recreational" drugs
History of malignancy not curatively treated at least 5 years before screening visit with exception of basal cell carcinoma in situ which may have been curatively treated within 1 year
Participation in another clinical trial within 30 days or 7 half-lives of the prior test product, whichever is longer
Any condition which, in the opinion of the investigator, might put the subject at risk by participation in this study

Sites / Locations

Hamad Medical CorporationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. Interventions: Patients will be given Fairhaven Pro for Men as antioxidant in a dose of 3 tablets twice daily for 3 months. Full assessment of fertility will be done.

Outcomes

Primary Outcome Measures

Evaluate the effect of antioxidant therapy on sperm motility in infertile men,

Measured by mean change in sperm motility pre- and post-treatment with antioxidants.

Evaluate the effect of antioxidant therapy on sperm morphology in infertile men

Measured by the mean change in sperm morphology pre- and post-treatment with antioxidants

Evaluate the effect of antioxidant therapy on sperm count in infertile men

Measured by mean change in sperm count pre- and post-treatment with antioxidants.

Secondary Outcome Measures

Evaluate the effect of antioxidant therapy on sperm DNA fragmentation in infertile men

Difference in mean change in sperm DNA fragmentation pre and post-treatment

Evaluate the effect of antioxidant therapy on oxidative stress in infertile men

Measure difference in mean change in seminal oxidation reduction potential in infertile men pre- and post-treatment.

Full Information

NCT ID

NCT03464656

First Posted

February 26, 2018

Last Updated

March 7, 2018

Sponsor

Hamad Medical Corporation

Collaborators

Fairhaven Health

1. Study Identification

Unique Protocol Identification Number

NCT03464656

Brief Title

Oxidative Stress In Semen And Male Infertility

Official Title

Oxidative Stress In Semen And Male Infertility

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

July 1, 2018 (Anticipated)

Study Completion Date

December 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hamad Medical Corporation

Collaborators

Fairhaven Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The proposed research aims to study the effects of antioxidant therapy, commonly used in male infertility treatment, on semen analysis. Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. They will be asked to provide a sample of semen for routine semen analysis and advanced semen tests including sperm DNA fragmentation and sORP before starting with antioxidant therapy and after 3-month treatment with antioxidants. After completing the data analysis, we intend to publish the study in high impact perr reviewed journals and present it in international conferences.

Detailed Description

The proposed research aims to study the effects of antioxidant therapy, commonly used in male infertility treatment, on semen analysis. Several studies have been conducted to evaluate the effect of many antioxidant regimens on male infertility. A randomized double-blind, placebo-controlled trial investigated a combined antioxidant regimen, including vitamin C, using Menevit (lycopene 6mg, vitamin E 400IU, vitamin C 100mg, zinc 25mg, selenium 26 mcg, folate 0.5mg, garlic 1g) in couples undergoing intracytoplasmic sperm injection. The authors reported a significant improvement in viable pregnancy rate in the treatment group, where 38.5% of transferred embryos resulted in a viable fetus compared to 16% in the placebo group (Tremellen K, 2007). Suleiman et al. studied 300 mg of daily vitamin E in a placebo-controlled study revealing significant improvement in sperm motility and reduction of oxidative stress measures in the treatment group. Moreover, they reported a 21% spontaneous pregnancy rate in the treatment group compared to 0% in the placebo group (Suleiman SA, 1996). Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. They will be asked to provide a sample of semen for routine semen analysis and advanced semen tests including sperm DNA fragmentation and sORP before starting with antioxidant therapy and after 3-month treatment with antioxidants. No other procedures will be done for research purposes. All other investigations or treatments will be given according to the standard of care. Routinely patients presenting to the male infertility unit at HMC seeking evaluation and treatment for delayed conception will be assessed with a history and physical examination, investigated with semen and endocrine studies and be placed on an antioxidant regimen comprised of vitamins C and E, L-Carnitine and pentoxyfylline. Further management will be individualized and planned according to each patient's condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Antioxidants, Infertility, Male, Semen Quality

Keywords

semen, male infertility, semen quality, sperm DNA fragmentation, oxidation reduction potential

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Single-center, prospective, comparative study

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Fairhaven Pro for men

Other Intervention Name(s)

Antioxidant

Intervention Description

Fairhaven Pro for men The antioxidant formula (Fairhaven Health) contains: B12 (1000 mcg) Zinc (30 mg) Selenium (140 mcg) Arginine (350 mg) L-carnitine tartrate (2000 mg) , providing 1,340 mg of L-carnitine CoQ10 (200 mg) Vitamin C (120 mg) and Vitamin E (200 IU)

Intervention Type

Diagnostic Test

Intervention Name(s)

Semen analysis

Other Intervention Name(s)

Semen test

Intervention Description

Full semen analysis according to WHO semen laboratory manual 5th edition will be done pre and 3 months post-treatment. After complete liquefaction, each sample was evaluated for both macroscopic parameters such as color, pH, ejaculate volume, age of the sample and viscosity. An aliquot of the sample was examined for sperm concentration, total sperm count, total and progressive motility and sperm morphology using the WHO fifth edition guidelines (WHO, 2010). Semen analysis was done manually using a hemocytometer. Sperm motility was assessed and categorized as progressive or non-progressive. Morphology was assessed by a single experienced technician using the Diff-Quik staining protocol. Kruger's strict criteria were used for morphology assessment with 4% normal morphology as a cut-off (WHO, 2010).

Intervention Type

Diagnostic Test

Intervention Name(s)

Sperm DNA fragmentation

Other Intervention Name(s)

SDF

Intervention Description

Sperm DNA fragmentation was evaluated using the Halosperm kit from Halotech DNA, S.L. (Madrid, Spain) as per manufacturer instructions. The method is based on the sperm chromatin dispersion test (Fernández et al., 2003). A minimum of 500 spermatozoa were scored and reported as percentage of sperm with spermatozoa with fragmented DNA. Normal value is measure at a cut-off value of more than 30%

Intervention Type

Diagnostic Test

Intervention Name(s)

Static Oxidation reduction potential in semen

Other Intervention Name(s)

sORP, Oxidative stress

Intervention Description

Oxidative stress was assessed by measuring the static oxidation-reduction potential (sORP) of neat liquefied semen samples using the MiOXSYSTM System (Aytu Bioscience, Inc., Englewood, USA). This is a galvanostatic measure of the electron transfer from reductants (antioxidants) to oxidants under a steady low voltage reducing current. Thus, providing an aggregate measure of all current oxidant activity and antioxidant activity in a sample. Higher sORP values (millivolts, mV) indicate a higher oxidant activity relative to the antioxidant activity and therefore greater state of oxidative stress.

Primary Outcome Measure Information:

Title

Evaluate the effect of antioxidant therapy on sperm motility in infertile men,

Description

Measured by mean change in sperm motility pre- and post-treatment with antioxidants.

Time Frame

1 year

Title

Evaluate the effect of antioxidant therapy on sperm morphology in infertile men

Description

Measured by the mean change in sperm morphology pre- and post-treatment with antioxidants

Time Frame

1 year

Title

Evaluate the effect of antioxidant therapy on sperm count in infertile men

Description

Measured by mean change in sperm count pre- and post-treatment with antioxidants.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Evaluate the effect of antioxidant therapy on sperm DNA fragmentation in infertile men

Description

Difference in mean change in sperm DNA fragmentation pre and post-treatment

Time Frame

1 year

Title

Evaluate the effect of antioxidant therapy on oxidative stress in infertile men

Description

Measure difference in mean change in seminal oxidation reduction potential in infertile men pre- and post-treatment.

Time Frame

1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Abnormal sperm parameters defined as having at least two out of the following three criteria: Sperm Concentration > 1 and ≤ 15 million per ml Sperm total Motility ≤ 40% Sperm Morphology by Strict Criteria; normal forms ≤ 4.0% Absence of infection in semen (pus cells < 1 X 106/ml) No history of taking any therapy for their infertility including OTC treatment and vitamin supplementation No history of obstructive azoospermia No history of testicular cancer Exclusion Criteria: Semen volume ≤ 1.5 mL Hydrocele, clinical varicocele (grade 2 and higher), orchitis, epididymitis, Cryptorchidism, irradiation or subjects that received chemotherapy treatment Clinically meaningful endocrinopathy defined as an endocrinopathy which requires endocrine medications (e.g. Diabetes, Thyroid disease, Pituitary diseases, Adrenal diseases, etc.) or measurement of the following hormonal values: Testosterone < 10.4 nmol/L LH <1 or > 9 IU/L and or FSH <1 or >19 IU/mL Elevated prolactin >407 mIU/L Elevated TSH > 4.5 U/mL Elevated Estrogen> 275 pmol/L Leukocytospermia: WBC count of > 1 X 106/ ml Known HIV infection Use of antioxidant agents or vitamins within 8 weeks prior to inclusion into the study Consumption of more than 1 unit of alcohol daily* Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc. History of current use of illegal or "recreational" drugs History of malignancy not curatively treated at least 5 years before screening visit with exception of basal cell carcinoma in situ which may have been curatively treated within 1 year Participation in another clinical trial within 30 days or 7 half-lives of the prior test product, whichever is longer Any condition which, in the opinion of the investigator, might put the subject at risk by participation in this study

Facility Information:

Facility Name

Hamad Medical Corporation

City

Doha

Country

Qatar

Individual Site Status

Recruiting

Facility Contact: