Clinical trial NCT03464656: Oxidative Stress In Semen And Male Infertility
Official title: Oxidative Stress In Semen And Male Infertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Antioxidants
Infertility, Male
Semen Quality
Keywords: semen
male infertility
semen quality
sperm DNA fragmentation
oxidation reduction potential
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Fairhaven Health
First posted: 2018-03-14
Enrollment: 100
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-center, prospective, comparative study
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Evaluate the effect of antioxidant therapy on sperm motility in infertile men,
timeFrame: 1 year
measure: Evaluate the effect of antioxidant therapy on sperm morphology in infertile men
timeFrame: 1 year
measure: Evaluate the effect of antioxidant therapy on sperm count in infertile men
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate the effect of antioxidant therapy on sperm DNA fragmentation in infertile men
timeFrame: 1 year
measure: Evaluate the effect of antioxidant therapy on oxidative stress in infertile men
timeFrame: 1 year
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
References: