An Open, Prospective, Double Blind, Randomised, Multicentre Study to Assess the Safety and Efficacy of Paternia in Male Infertility

Not provided5 sites in 1 country140 target enrollmentStarted: TBD

Conditions

Trial Snapshot

Phase: Not Applicable
Enrollment: 140
Locations: 5
Primary Endpoint: Improvement in sperm count, motility, morphology, motility index, teratozoospermia index (TZI), Fertilization potential by HOS test

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This study is an randomized, double blind, comparative, multicentric placebo controlled study comparing the safety and efficacy of two dosage schedules of Paternia tablets as one tablet twice daily or two tablets twice daily each for 360 days in 140 male patients with infertility that will be conducted in five centers in India. The primary outcome measures will be the improvement in sperm count, motility, morphology, motility index, teratozoospermia index (TZI) and fertilization potential by HOS test.

Study Design

Allocation: Computer generated randomization
Masking: Participant and Outcome Assessor Blinded

Eligibility Criteria

Inclusion Criteria

•1.Age between 21 to 50 years2.Sperm count ?
•< 50 million/cu mm3.Sperm motility < 50 % (according to World Health Organization [WHO] 1999 criteria)4.Normal Sperm morphology < 50 %5.No history of taking therapy for infertility6.No history of obstructive azoospermia 7.Normal female partner8.Willing to sign Informed consent9.Subjects likely to be available for all visits during follow-up period.

Exclusion Criteria

•1.Any organic cause for male factor infertility2.Prostato-vesiculo-epididymitis 3.Not planning for IVF etc in the proposed study period4.Abnormal hormonal profile: gonadotropins, T, E 2, and PRL, FSH>155.Presence of antispermatozoa antibodies6.Severe oligospermia 7.Varicocoele8.Azoospermia 9.Presence of infectious genital diseases10.Seminal white blood cells (WBCs) more than 1 x 10 6/mL11.Major hepatic and Renal disease12.Myopathy 13.Primary testicular diseaease14.Subject with history of allergy to any ingredient of the formulation15.Subject not likely to be available for follow-up.16.Participation in another clinical trial in the past 3 months.

Outcomes

Primary Outcomes

Improvement in sperm count, motility, morphology, motility index, teratozoospermia index (TZI), Fertilization potential by HOS test

Time Frame: Day 0, 90, 180, 270 & 360

Secondary Outcomes

Pregnancy Rate(Day 0, 30, 60, 90, 180, 270 & 360)

Investigators

Sponsor

Not provided

Study Sites (5)

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