Idiopathic InfertilityPhase 4NeotilityNCT03104998
Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility
A Phase 4 study testing Coenzyme Q10 in people with Idiopathic Infertility, run by PharmEvo Pvt Ltd at 1 site in Pakistan.
Trial summary
To study the effect of coenzyme Q10 on semen parameters in men with idiopathic infertility Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Idiopathic Infertility
- What is being tested?
- Coenzyme Q10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2017to 30 May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To study the effect of coenzyme Q10 on semen parameters in men with idiopathic infertility
Read the detailed description
Decreased serum CoQ10 concentrations as well as a decrease in the CoQ10H2 to-ubiquinone ratio have been demonstrated in diseases associated with OS. A strong correlation among sperm count, motility and ubiquinol-10 levels in seminal fluid has also been reported.
The aim of the present study is to investigate whether the effects of the exogenous administration of ubiquinol in the improvement of semen parameters in Pakistani men population.
Patients who full filled the inclusion criteria and gave informed written consent will be included in the trial. Patient will start to take medication and will take it for 26 weeks.
All men undergo a thorough physical examination, a detail history, serum biochemical and hematological laboratory tests and measurement of serum sex and thyroid hormone levels. A questionnaire will be used to collect information on demographic characteristics. Two semen samples 1 and 2 month apart will be obtained after 3 to 5 days of sexual abstinence and process within 1 hour of ejaculation. The mean of the two will be used for statistical analysis. Semen analyses will be performed using WHO recommended methods.
3 ml of blood will be withdrawn from the patient for the serum hormones analysis and total amount of semen will required for analysis of semen parameters.
Sponsor will bear the test cost of patient during the study treatment period.
- Conditions
- Idiopathic Infertility
- Being tested
- Coenzyme Q10
- Keywords
- Idiopathic, Infertility, coenzyme q10, Pakistan
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Drug
Also called NeoQ10
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
| Study group | Role | What they receive |
|---|---|---|
| coenzyme Q10 | Other | Dose of 200 mg of CoQ10 taken daily by mouth from day 1 till 26 weeks Receives: Drug: Coenzyme Q10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 weeks
Secondary outcomes (1)
Adverse Event
Proportion of participants experiencing an adverse event (AE) leading to permanent discontinuation of study medication [Designated as safety issue: Yes]
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Aug 2017
- Primary completion30 Mar 2018
- Study completion30 May 2018 (estimated)
Why it stopped: No further patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmEvo Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masood Jawaid, MRCS,FCPS, Study chair, PharmEvo Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104998
- Sponsor's protocol ID
- PE/PK/Neotility/SP/2017-01
- Acronym
- Neotility
- Status last verified
- Mar 2017
- First submitted
- 28 Mar 2017
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35506389
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility
- ClinicalTrials.gov ID
- NCT03104998
- Acronym / sponsor ID
- Neotility / PE/PK/Neotility/SP/2017-01
- Conditions
- Idiopathic Infertility
- Keywords
- Idiopathic, Infertility, coenzyme q10, Pakistan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No further patient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PharmEvo Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effect of coenzyme Q10 on semen parameters in men with idiopathic infertility
Detailed description
Decreased serum CoQ10 concentrations as well as a decrease in the CoQ10H2 to-ubiquinone ratio have been demonstrated in diseases associated with OS. A strong correlation among sperm count, motility and ubiquinol-10 levels in seminal fluid has also been reported.
The aim of the present study is to investigate whether the effects of the exogenous administration of ubiquinol in the improvement of semen parameters in Pakistani men population.
Patients who full filled the inclusion criteria and gave informed written consent will be included in the trial. Patient will start to take medication and will take it for 26 weeks.
All men undergo a thorough physical examination, a detail history, serum biochemical and hematological laboratory tests and measurement of serum sex and thyroid hormone levels. A questionnaire will be used to collect information on demographic characteristics. Two semen samples 1 and 2 month apart will be obtained after 3 to 5 days of sexual abstinence and process within 1 hour of ejaculation. The mean of the two will be used for statistical analysis. Semen analyses will be performed using WHO recommended methods.
3 ml of blood will be withdrawn from the patient for the serum hormones analysis and total amount of semen will required for analysis of semen parameters.
Sponsor will bear the test cost of patient during the study treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coenzyme Q10 | Other | Drug: Coenzyme Q10Dose of 200 mg of CoQ10 taken daily by mouth from day 1 till 26 weeks |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10Also: NeoQ10200 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 | Drug | coenzyme Q10 |
Primary outcome
Measure the change in semen parameters after 26 Weeks of coenzyme q10.
Time frame: 26 weeks
To measure the change in semen parameters after 26 Weeks of coenzyme q10. Designated as safety issue: No
1 secondary outcome
Adverse Event
Time frame: 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Derived from this study: PubMed 35506389de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masood Jawaid, MRCS,FCPS study chair
PharmEvo Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coenzyme Q10 in people with Idiopathic Infertility, run by PharmEvo Pvt Ltd at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the change in semen parameters after 26 Weeks of coenzyme q10. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03104998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.