A clinical trial to study the effects of Paternia in male patients with Infertility

• Conditions: Male Infertility

• Registration Number: CTRI/2010/091/000574

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.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 140

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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in sperm count, motility, morphology, motility index, teratozoospermia index (TZI), Fertilization potential by HOS test	Day 0, 90, 180, 270 & 360

Secondary Outcome Measures

Name	Time	Method
Pregnancy Rate	Day 0, 30, 60, 90, 180, 270 & 360

Trial Locations

Locations (5)

Bharti Research Institute of Diabetes & Endocrinology (BRIDE), Haryana; 🇮🇳 Karnal, HARYANA, India

Men's Health Clinic, Indore, Madhya Pradesh; 🇮🇳 Indore, MADHYA PRADESH, India

Menz Health Clinic, Uttar Pradesh; 🇮🇳 Sector, India

Sooriya Hospital, Chennai; 🇮🇳 Chennai, TAMIL NADU, India

Southend Fertility & IVF Centre, Holy Angels Hospital, New Delhi; 🇮🇳 Delhi, DELHI, India

Bharti Research Institute of Diabetes & Endocrinology (BRIDE), Haryana

🇮🇳Karnal, HARYANA, India

Dr. Bharti Kalra

Principal investigator

brideknl@gmail.com