ClinicalTrials.gg
RecruitingNCT06342856infertilityUpdated Apr 2, 2024

Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia

An Early Phase 1 interventional study of co enzyme Q10 , L- Carnitine in Infertility Unexplained and Oligospermia, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to male participants. Per ClinicalTrials.gov, last updated 2024-04-02.

Sponsored by Ain Shams University · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Registered 8 months after the study started (first participant enrolled Jun 2023, registered Mar 2024).
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
120
Allocation
Randomized
Sex
Male
01

Study summary

Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia

Read the detailed description

Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia a placebo controlled clinical trial

02

Conditions studied

  • Infertility Unexplained
  • Oligospermia

Keywords

  • infertility
  • oligospermia
  • coenzyme Q1o
03

In context

Oligospermia

64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.

This study's planned enrollment of 120 is above the median of 65 across 46 interventional studies indexed under Oligospermia.

Browse Oligospermia studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • of in¬fertility of 1 year or more without the use of

Exclusion criteria

Exclusion Criteria:

  • o Active genital infections.

    • Patients with ejaculatory dysfunction
    • Azoospermia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Group 1

    will receive a daily dose of 200 mg of CoQ10 for 3 months

    Drug: co enzyme Q10 , L- Carnitine

  • Active comparator
    Group 2

    will receive L-carnitine 1 tablet per day orally for 3 months

    Drug: co enzyme Q10 , L- Carnitine

  • Active comparator
    Group 3

    will receive combination of a daily dose of 200 mg of CoQ10 and 1 tablet of L-carnitine for 3 months

    Drug: co enzyme Q10 , L- Carnitine

  • Placebo comparator
    Group 4

    will receive a placebo for 3 months

    Drug: co enzyme Q10 , L- Carnitine

Interventions

  • Drugco enzyme Q10 , L- Carnitine

    Drug pages: Coenzyme Q10 · Carnitine

    Patient fulfilling inclusion criteria after obtaining consent will be randomized into four equal groups randomization will be computer based

06

What researchers measure

Primary outcomes

  1. Changes in Semen analysis parameters compared to baseline

    Changes in Semen analysis parameters compared to baseline

    Time frame: 6 months

Secondary outcomes

  1. Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis

    Serum hormone levels (\[FSH\], \[LH\], testosterone, and prolactin) levels compared to baseline and Cost analysis

    Time frame: 6 moths

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Salvio G, Cutini M, Ciarloni A, Giovannini L, Perrone M, Balercia G. Coenzyme Q10 and Male Infertility: A Systematic Review. Antioxidants (Basel). 2021 May 30;10(6):874. doi: 10.3390/antiox10060874. PubMed 34070761 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2023 (actual). Primary completion is estimated for Jun 2024, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2024
First posted
Apr 2, 2024
StartActual
Jun 15, 2023
Primary completionEst.
Jun 1, 2024
CompletionEst.
Jul 1, 2024
Last update
Apr 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06342856
Responsible party
Sponsor
First posted
Apr 2, 2024
Start date
Jun 15, 2023
Primary completion
Jun 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Apr 2, 2024

Study contacts

waleed,mo abdelhamid, ass lecturer
Contact
drwaleedabdelhamid@gmail.com
01013340534 ext. wa

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drugs tested here: Coenzyme Q10 · Carnitine

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