NCT06342856

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 2, 2024

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

March 8, 2024

Last Update Submit

March 29, 2024

Conditions

Infertility UnexplainedOligospermia

Keywords

infertilityoligospermiacoenzyme Q1o

Outcome Measures

Primary Outcomes (1)

  • Changes in Semen analysis parameters compared to baseline

    Changes in Semen analysis parameters compared to baseline

    6 months

Secondary Outcomes (1)

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

    6 moths

Study Arms (4)

Group 1

ACTIVE COMPARATOR

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

Drug: co enzyme Q10 , L- Carnitine

Group 2

ACTIVE COMPARATOR

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

Drug: co enzyme Q10 , L- Carnitine

Group 3

ACTIVE COMPARATOR

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

Group 4

PLACEBO COMPARATOR

will receive a placebo for 3 months

Drug: co enzyme Q10 , L- Carnitine

Interventions

co enzyme Q10 , L- CarnitineDRUG

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

Group 1Group 2Group 3Group 4

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility Detailssemen analysis
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • o Active genital infections.
  • Patients with ejaculatory dysfunction
  • Azoospermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 002, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34070761RESULT

MeSH Terms

Conditions

OligospermiaInfertility

Interventions

UbiquinoneCarnitine

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzoquinonesQuinonesOrganic ChemicalsCoenzymesEnzymes and CoenzymesTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAmines

Central Study Contacts

waleed,mo abdelhamid, ass lecturer

CONTACT

01013340534drwaleedabdelhamid@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2024

First Posted

April 2, 2024

Study Start

June 15, 2023

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

April 2, 2024

Record last verified: 2023-08

Locations

EG(1)