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

Not Applicable

• Conditions: Health Condition 1: N469- Male infertility, unspecified

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Male subjects above the age of 21 years, in a monogamous, heterosexual marriage, trying to conceive but having difficulty with conception.

2. Subjects with Sperm DNA Fragmentation Index >=15% at the time of screening.

3. Subjects with normal or clinically non-normal seminal parameters not limited to hemospermia, leucospermia.

4. Subjects whose female partners have not conceived after 1 year of unprotected vaginal sexual intercourse; with or without history of ART treatments.

5. Subjects with primary or secondary infertility.

6. 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.

2. Subjects who have history/diagnosis of cancer inclusive of subjects in remission.

3. Subjects with testicular atrophy and congenital abnormalities not limited to absence of vas deferens.

4. Subjects who are currently on or were on a antioxidant and/or vitamin supplements upto 3 months prior to screening.

5. Subjects with history of substance abuse.

6. Subjects with diagnosis of HIV, HCV, HBV and other sexually transmitted diseases.

7. Subjects with known history of clinically significant, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, neurological abnormalities or diseases.

8. Subjects who have undergone major surgical procedure 4 weeks prior to screening.

9. 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.

11. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.

12. 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 â?¥5% DFI from baseline to end of study. <br/ ><br>2.Sperm DNA Fragmentation Index : Reduction of â?¥10% DFI from baseline to end of study. <br/ ><br>3.Sperm DNA Fragmentation Index : â?¤15% DFI by end of study,provided that the reduction is â?¥5% DFI. <br/ ><br>4.Subject Compliance and Satisfacation: Score of â?¥ 20 by end of study. <br/ ><br>Timepoint: 1.Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90). <br/ ><br>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. <br/ ><br>2.Subject Compliance and Satisfacation: Score of 15-19 by end of study. <br/ ><br>Timepoint: 1.Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90). <br/ ><br>2.Subject Compliance and Satisfacation:At Visit 2(Day 45), Visit 3 ( day 90). <br/ ><br>