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

NCT05200663 | Unknown Phase 2

• 1 other identifier: SMDC/SMRC/213-21/2021
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tamoxifen citerate; Anti oxidants

Outcome Measures

Primary Outcomes (18)

• Semen Volume

  Semen Volume measured in ml.

  at 3 months posttreatment

• Semen Volume

  Semen Volume measured in ml.

  at 6 months posttreatment

• Total sperm Count

  Total Sperm No.(x106)

  3 months posttreatment

• Total sperm Count

  Total Sperm No.(x106):

  6 months posttreatment

• Sperm concentration

  Sperm Conc. (x106)/ ejeculate:

  3 months posttreatment

• Sperm concentration

  Sperm Conc. (x106)/ ejeculate:

  6 months posttreatment

• Progressive motility

  Progressive motility in (Percentage %):

  3 months posttreatment.

• Progressive motility

  Progressive motility (Percentage %):

  6 months posttreatment

• Sperm Morphology:

  Sperm Morphology: Percentage %

  3 months posttreatment

• Sperm Morphology:

  Sperm Morphology: Percentage %

  6 months posttreatment

• Vitality

  Vitality (live spermatozoa in percentage%

  3 months posttreatment

• Vitality

  Vitality (live spermatozoa) in percentage%

  6 months posttreatment

• Leutinizing hormone

  Leutinizing hormone (LH) measured in mU/ml

  3 months posttreatment

• Leutinizing hormone

  Leutinizing hormone (LH) measured in mU/ml

  6 months posttreatment

• Follicular stimulating hormone

  Follicular stimulating hormone (LH) measured in mU/ml Follicular stimulating hormone (FSH) measured in mU/ml

  3 months posttreatment.

• Follicular stimulating hormone

  Follicular stimulating hormone (LH) measured in mU/ml Follicular stimulating hormone (FSH) measured in mU/ml

  6 months posttreatment.

• Serum Testosterone

  Serum Testosterone measured in ng/dl

  3 months posttreatment.

• Serum Testosterone

  Serum Testosterone measured in ng/dl

  6 months posttreatment.

Study Arms (2)

"Tamoxifen"

EXPERIMENTAL

Group A patients will receive tab tamoxifen 10 mg twice a day for total of six months.

Drug: Tab Tamoxifen 10 mg

"Tamoxifen and Antioxidant"

ACTIVE COMPARATOR

Group B patients will receive tab tamoxifen 10 mg twice a day and cap. vit E 400mg once a day for total of six months.

Drug: Tab Tamoxifen 10mg,Cap vitamin E 400mg

Interventions

Tab Tamoxifen 10 mg DRUG

Tablet tamoxifen 10mg twice a day for 6 months.

Also known as: Group A

"Tamoxifen"

Tab Tamoxifen 10mg,Cap vitamin E 400mg DRUG

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

Also known as: Group B

"Tamoxifen and Antioxidant"

Eligibility Criteria

• Gender Eligibility Details: All infertile males fulfilling the inclusion criteria.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All infertile male with idiopathic infertility and abnormal semen analysis.

You may not qualify if:

• \. Leukocytospermia i.e. significant WBCs seen in the semen, 2. Severe oligospermia (sperm count \<5 million per ml),

Sponsors & Collaborators

• Sharif Medical Research Center: lead

Study Sites (1)

Sharif Medical And Dental College

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (9)

• Meng Q, Ren A, Zhang L, Liu J, Li Z, Yang Y, Li R, Ma L. Incidence of infertility and risk factors of impaired fecundity among newly married couples in a Chinese population. Reprod Biomed Online. 2015 Jan;30(1):92-100. doi: 10.1016/j.rbmo.2014.10.002. Epub 2014 Oct 13.

  PMID: 25456165 RESULT

• Butt F, Akram N. Semen analysis parameters: experiences and insight into male infertility at a tertiary care hospital in Punjab. J Pak Med Assoc. 2013 May;63(5):558-62.

  PMID: 23757979 RESULT

• Safarinejad MR. The effect of coenzyme Q(1)(0) supplementation on partner pregnancy rate in infertile men with idiopathic oligoasthenoteratozoospermia: an open-label prospective study. Int Urol Nephrol. 2012 Jun;44(3):689-700. doi: 10.1007/s11255-011-0081-0. Epub 2011 Nov 13.

  PMID: 22081410 RESULT

• Siddiq FM, Sigman M. A new look at the medical management of infertility. Urol Clin North Am. 2002 Nov;29(4):949-63. doi: 10.1016/s0094-0143(02)00085-x.

  PMID: 12516764 RESULT

• 5. Iacono F, Prezioso D, Ruffo A et al. Treating idiopathic male infertility with a combination of tamoxifen citrate and a natural compost of antioxidant and androgen mimetic action. J Steroid Hormone Sci. 2013;S5: 1-6.

  RESULT

• Kadioglu TC. Oral tamoxifen citrate treatment is more effective in normogonadotropic patients who have follicle-stimulating hormone levels within the lower half of normal. Int Urol Nephrol. 2009 Dec;41(4):773-6. doi: 10.1007/s11255-009-9568-3. Epub 2009 Apr 21.

  PMID: 19381855 RESULT

• Adamopoulos DA. Medical treatment of idiopathic oligozoospermia and male factor subfertility. Asian J Androl. 2000 Mar;2(1):25-32.

  PMID: 11228933 RESULT

• Nada EA, El Taieb MA, Ibrahim HM, Al Saied AE. Efficacy of tamoxifen and l-carnitine on sperm ultrastructure and seminal oxidative stress in patients with idiopathic oligoasthenoteratozoospermia. Andrologia. 2015 Sep;47(7):801-10. doi: 10.1111/and.12333. Epub 2014 Oct 2.

  PMID: 25274200 RESULT

• Sharma RK, Agarwal A. Role of reactive oxygen species in male infertility. Urology. 1996 Dec;48(6):835-50. doi: 10.1016/s0090-4295(96)00313-5.

  PMID: 8973665 RESULT

MeSH Terms

Conditions

Oligospermia; Infertility, Male

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Anees Fatima, MBBS,FCPS

  Sharif Medical And Dental College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anees Fatima, MBBS,FCPS.

CONTACT

03456224197; fatima.tabjeel@gmail.com

Fauzia Butt, MBBS,FCPS,

CONTACT

03009427094; drfauziabutt@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It is single blinded study in which 110 patients are recruited into two groups .Randomization will be done by lottery method to divide the patients into group A \& group B. 55 patients in group A will be given tamoxifen 10 mg twice a day and 55 patients in group B will be given tamoxifen 10 mg twice a day and vit E 400mg once a day. Only researcher will be knowing that which treatment will be giving to which group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 110 patients are recruited into two groups .55 patients in group A will be given tamoxifen 10 mg twice a day and 55 patients in group B will be given tamoxifen 10 mg twice a day and vit E 400mg once a day.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 21, 2022
• Study Start: October 15, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 21, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)