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

Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram and Sex Hormone in Iraqi Infertile Men; A Comparative Study

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Male; Male Reproductive Problem
• Intervention / Treatment: Drug: Letrozole tablets; Dietary supplement: Coenzyme Q10 table

Detailed Description

We will evaluate the impacts of adding coenzyme Q10 to letrozole on spermiogram and sex hormone in men diagnosed with idiopathic oligo/astheno/ teratozoospermia (iOAT) syndrome.

The study will include 67 patients which will be randomly separated into two groups, Group (A) 29 patients will be treated with letrozole 2.5mg tablet orally twice a week, Group (B) 38 patient will be treated with a combination of letrozole 2.5 mg tablet orally twice a week plus Co-Q10 400mg per day, both groups complete treatment for three months. Semen sample, serum FSH, estradiol (E2), and testosterone (T) were analyzed at day one, and at the end of one, two, and three months.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 12221
    • specialized center of infertility/ Nahrain University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group A; group A (29) patients received letrozole 2.5mg twice weekly for 3 months	Drug: Letrozole tablets; letrozole 2.5mg twice weekly for 3 months
Experimental: Group B; Group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months	Drug: Letrozole tablets; letrozole 2.5mg twice weekly for 3 months; Dietary supplement: Coenzyme Q10 table; Coenzyme Q10 400 mg per day for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
hormone profile	concentration of Serum FSH, concentration of Serum estradiol, and concentration of Serum testosterone	change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment

Collaborators and Investigators

• Sponsor: Al-Mustansiriyah University
• Collaborators: Al-Nahrain University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Estimate): May 8, 2023

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Male; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Micronutrients; Hormone Antagonists; Vitamins; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: 2023M01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All participants demographical and clinical characteristics, and outcome of the study
• IPD Sharing Time Frame: Upon publication of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No