Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram

NCT05847257 | Completed Phase 2 DMC

• 1 other identifier: 2023M01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Worldwide infertility affects about 15 % of reproductive-age couples. In many cases, infertility can't be treated, new treatment options with promising value were involved in the recent clinical trials.

Conditions

Male Reproductive Problem; Infertility, Male

Outcome Measures

Primary Outcomes (1)

• The seminal fluid analysis

  sperm volume/ ml, Sperm concentration/ml, Total sperm count / ml, Progressive Sperm motility (%), Non-progressive Sperm motility (%), Immotile Sperm (%), Normal Sperm morphology (%)

  change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment

Secondary Outcomes (1)

• hormone profile

  change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment

Study Arms (2)

Group A

SHAM COMPARATOR

group A (29) patients received letrozole 2.5mg twice weekly for 3 months

Drug: Letrozole tablets

Group B

EXPERIMENTAL

Group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months

Drug: Letrozole tablets; Dietary Supplement: Coenzyme Q10 table

Interventions

Letrozole tablets DRUG

letrozole 2.5mg twice weekly for 3 months

Group A; Group B

Coenzyme Q10 table DIETARY_SUPPLEMENT

Coenzyme Q10 400 mg per day for 3 months

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: All male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult male patients.
• Aged 18 - 60 years.
• Confirmed diagnosis with idiopathic Oligo-Astheno-Teratozoospermia (iOAT) syndrome.

You may not qualify if:

• Patients who have been found to have additional infertility causes, such as varicocele or Obstruction of the ejaculatory duct.
• Those who have had surgery for male factor infertility.
• Patients with infections such as STD.
• Patient with renal or liver disease
• Incomplete patient data

Sponsors & Collaborators

• Al-Mustansiriyah University: lead
• Al-Nahrain University: collaborator

Study Sites (1)

specialized center of infertility/ Nahrain University

Baghdad, 12221, Iraq

Location

Related Publications (1)

• Fadhil EB, Mohammed MM, Alkawaz UM. Impact of coenzyme Q10 as an adjuvant therapy to letrozole on spermiogram results and sex hormone levels in Iraqi men with infertility; randomized open label comparative study. F1000Res. 2024 Jun 10;12:1093. doi: 10.12688/f1000research.131985.3. eCollection 2023.

  PMID: 38957201 DERIVED

Related Links

• Publication

MeSH Terms

Conditions

Infertility, Male

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associated professor

Model Details: A prospective clinical study. The study initially included 74 patients, on follow-up 7 cases were lost and the final analysis involved 67 cases. These patients were further divided into two groups randomly, group A (29) patients received letrozole 2.5mg twice weekly for 3 months, and group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months. Patients with idiopathic Oligo-Astheno-Teratozoospermia (iOAT) syndrome were selected during their visit to the specialized center of infertility/ Nahrain University. Before taking part, each subject provided their written, informed consent. The duration of this study was from December 2021 till October 2022.

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 6, 2023
• Study Start: December 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon publication of the study

Locations

IR (1)