Study Stopped
No further patient enrollment
Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility
Neotility
1 other identifier
interventional
N/A
1 country
1
Brief Summary
To study the effect of coenzyme Q10 on semen parameters in men with idiopathic infertility
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2018
CompletedSeptember 17, 2018
March 1, 2017
8 months
March 28, 2017
September 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure the change in semen parameters after 26 Weeks of coenzyme q10.
To measure the change in semen parameters after 26 Weeks of coenzyme q10. Designated as safety issue: No
26 weeks
Secondary Outcomes (1)
Adverse Event
26 weeks
Study Arms (1)
coenzyme Q10
OTHERDose of 200 mg of CoQ10 taken daily by mouth from day 1 till 26 weeks
Interventions
200 mg of CoQ10 or placebo daily by mouth from day 1 till 26 weeks. CoQ10 treatment is safe, even at the highest doses cited in the literature. Most clinical trials have not reported significant adverse effects that necessitated stopping therapy. However, gastrointestinal effects such as abdominal discomfort, nausea, vomiting, diarrhea, and anorexia have occurred. Allergic rash and headache have also been reported
Eligibility Criteria
You may qualify if:
- To sign the Informed Consent form
- Patients will be recruited in the study if they will fulfilled the criteria of history of primary infertility of more than 2 years, abnormal sperm count and motility
- age between 20 and 50 years
- No known medical or surgical condition which can result in infertility
You may not qualify if:
- Voluntary withdrawal
- Poor compliance of visit/treatment
- A history of cancer chemotherapy or radiotherapy
- A history of genital disease such as cryptorchidism and varicocele; a history of genital surgery
- Body mass index 30 kg/m or greater; any endocrinopathy
- Ychromosome microdeletions or karyotype abnormalities
- leukocytospermia
- Drug or substance abuse; tobacco use;
- Use of anticonvulsants, androgens or antiandrogens
- Significant liver (serum bilirubin greater than 2.0 mg/dl)
- Renal function (serum creatinine greater than 2.0 mg/dl) impairment
- Patients with severe oligozoospermia (less than 5 X 106/ml), azoospermia and testicular volume less than 12 ml will also excluded from study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PharmEvo Pvt Ltdlead
Study Sites (1)
HillPark Hospital
Karachi, Pakistan
Related Publications (1)
de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.
PMID: 35506389DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Masood Jawaid, MRCS,FCPS
PharmEvo Pvt Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2017
First Posted
April 7, 2017
Study Start
August 1, 2017
Primary Completion
March 30, 2018
Study Completion
May 30, 2018
Last Updated
September 17, 2018
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share