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Efficacy Comparison of Tamoxifen and Tamoxifen With Antioxidants on Semen Quality of Male With Idiopathic Infertility

NCT05200663 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-01-21

No results posted yet for this study

Summary

Objective of the study is to compare the efficacy of tamoxifen alone \& tamoxifen with antioxidant on semen quality of infertile male with abnormal parameters (sperm count, motility, vitality, morphology) .Infertility is defines as inability to conceive after one year of unprotected and regular intercourse. Infertility is the most important issue in the married couples and is one of the major clinical problem affecting people medically and psychologically .It affects about 5.8 to 44.2 % couples in the developing countries. Male infertility contributes to about 50% of the overall infertility. Antiestrogens are considered as one of the old and most commonly prescribed treatment of idiopathic infertility.Many studies has shown that it improves idiopathic oligozoospermia, count, motility and vitality. Spermatozoa are also prone to oxidative damage.

Men who have high reactive oxygen species(ROS) may have lower fertility potential as compared to men with low ROS. High levels of ROS in semen have been correlated with reduced sperm motility and damage to sperm nuclear DNA. High levels of cytokines in the semen is correlated with sperm injury like cell membrane lipid peroxidation in the presence of raised IL-6 .Antioxidents are the most important form of protection for spermatozoa against ROS. So oral antioxidents are commonly prescribed to males with idiopathic abnormal semen parameters and infertility to reduce the oxidative stress and improves infertility.

It is a single blinded randomized control trial to be conducted in Sharif Medical and Dental college, Lahore with sampling technique of probability randomized consecutive sampling technique. 110 male patients with idiopathic male infertility and abnormal semen parameters will be recruited . Pre treatment semen analysis and LH, FSH and serum testosterone will be done. 55 patients will be given tamoxifen alone ad 55 patients will be given tamoxifen with antioxidant. Then at the interval of 3 and 6 months after treatment , semen analysis and hormonal profile will be repeated. Pre-treatment and post treatment semen parameters will be compared using paired sample t-test. P-value \< 0.05 will be taken as significant.

Conditions

  • Oligoasthenoteratozoospermia
  • Male Infertility

Interventions

DRUG

Tab Tamoxifen 10 mg

Tablet tamoxifen 10mg twice a day for 6 months.

DRUG

Tab Tamoxifen 10mg,Cap vitamin E 400mg

Tab tamoxifen 10 mg is given twice a day and cap vit E 400mg is given once a day for 6 months

Sponsors & Collaborators

  • Sharif Medical Research Center

    lead OTHER

Principal Investigators

  • Anees Fatima, MBBS,FCPS · Sharif Medical And Dental College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05200663 on ClinicalTrials.gov