Clinical Study on D-Frag Tablets for improving Sperm Quality (Sperm DNA)

Recruiting

• Conditions: Male infertility, unspecified,

• Registration Number: CTRI/2018/10/016090
• Lead Sponsor: Nutri Synapzz Therapeutix Private Limited

Brief Summary

**StudyDesign:**An OpenLabel, Prospective, Non-Comparative, Single Arm Clinical Study.

**StudyPopulation:**Males abovethe age of 21 years in a monogamous, heterosexual marriage, trying to conceivebut having difficulty with conception.

**Indication:**Male Infertility (Sperm DNAFragmentation)

**Investigational Product Test:**DFrag Tablets

**InvestigationalProduct Comparator:**None.(Non-comparative, single arm study)

**Dosage:**1 BD x 3 months (1 tablet in themorning and 1 tablet in the night for 3 months)

**StudyDuration:**3 months

**Number ofSubjects:**66 subjects(so as to reach 60 evaluable subjects)

**Assessments:**

1. Sperm DNA Fragmentation Index

2. Subject IP Feedback Questionnaire

3. Complete Blood Count

4. Serum Biochemistry (including LFTand RFT)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-30
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

• Male subjects above the age of 21 years, in a monogamous, heterosexual marriage, trying to conceive but having difficulty with conception.
• Subjects with Sperm DNA Fragmentation Index ≥15% at the time of screening.
• Subjects with normal or clinically non-normal seminal parameters not limited to hemospermia, leucospermia.
• Subjects whose female partners have not conceived after 1 year of unprotected vaginal sexual intercourse; with or without history of ART treatments.
• Subjects with primary or secondary infertility.
• Subjects who are willing to commit to study restrictions not limited to abstinence from masturbation and sexual intercourse for specific periods.

Exclusion Criteria

• Subjects who have aspermia, azoospermia, cryptozoospermia.
• Subjects who have history/diagnosis of cancer inclusive of subjects in remission.
• Subjects with testicular atrophy and congenital abnormalities not limited to absence of vas deferens.
• Subjects who are currently on or were on a antioxidant and/or vitamin supplements upto 3 months prior to screening.
• Subjects with history of substance abuse.
• Subjects with diagnosis of HIV, HCV, HBV and other sexually transmitted diseases.
• Subjects with known history of clinically significant, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, neurological abnormalities or diseases.
• Subjects who are on steroids, hormone therapy, anti-depressants, anti-psychotics.
• 10.Subjects who have participated in another clinical study upto 3 months prior to screening.
• Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
• Subjects who in the opinion of the investigator are deemed unfit to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Sperm DNA Fragmentation Index : Reduction of ≥5% DFI from baseline to end of study.	1.Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90). | 2.Subject Compliance and Satisfacation:At Visit 2(Day 45), Visit 3 ( day 90).
2.Sperm DNA Fragmentation Index : Reduction of ≥10% DFI from baseline to end of study.	1.Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90). | 2.Subject Compliance and Satisfacation:At Visit 2(Day 45), Visit 3 ( day 90).
3.Sperm DNA Fragmentation Index : ≤15% DFI by end of study,provided that the reduction is ≥5% DFI.	1.Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90). | 2.Subject Compliance and Satisfacation:At Visit 2(Day 45), Visit 3 ( day 90).
4.Subject Compliance and Satisfacation: Score of ≥ 20 by end of study.	1.Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90). | 2.Subject Compliance and Satisfacation:At Visit 2(Day 45), Visit 3 ( day 90).

Secondary Outcome Measures

Name	Time	Method
1.Sperm DNA Fragmentation Index : Reduction of 3-4% DFI from baseline to end of study.	2.Subject Compliance and Satisfacation: Score of 15-19 by end of study.

Trial Locations

Locations (1)

Indira IVF Hospital Private Limited; 🇮🇳 Udaipur, RAJASTHAN, India

Indira IVF Hospital Private Limited

🇮🇳Udaipur, RAJASTHAN, India

Dr Kshitiz Murdia

Principal investigator

9799112244

drkshitiz@yahoo.com