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

Primary Purpose

Male Reproductive Problem, Infertility, Male

Status
Completed
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Letrozole tablets
Coenzyme Q10 table
Sponsored by
Al-Mustansiriyah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Reproductive Problem

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • specialized center of infertility/ Nahrain University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 (%)

Secondary Outcome Measures

hormone profile
concentration of Serum FSH, concentration of Serum estradiol, and concentration of Serum testosterone

Full Information

First Posted
April 10, 2023
Last Updated
April 26, 2023
Sponsor
Al-Mustansiriyah University
Collaborators
Al-Nahrain University
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1. Study Identification

Unique Protocol Identification Number
NCT05847257
Brief Title
Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram
Official Title
Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram and Sex Hormone in Iraqi Infertile Men; A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Mustansiriyah University
Collaborators
Al-Nahrain University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Reproductive Problem, Infertility, Male

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Sham Comparator
Arm Description
group A (29) patients received letrozole 2.5mg twice weekly for 3 months
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months
Intervention Type
Drug
Intervention Name(s)
Letrozole tablets
Intervention Description
letrozole 2.5mg twice weekly for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10 table
Intervention Description
Coenzyme Q10 400 mg per day for 3 months
Primary Outcome Measure Information:
Title
The seminal fluid analysis
Description
sperm volume/ ml, Sperm concentration/ml, Total sperm count / ml, Progressive Sperm motility (%), Non-progressive Sperm motility (%), Immotile Sperm (%), Normal Sperm morphology (%)
Time Frame
change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment
Secondary Outcome Measure Information:
Title
hormone profile
Description
concentration of Serum FSH, concentration of Serum estradiol, and concentration of Serum testosterone
Time Frame
change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
All male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male patients. Aged 18 - 60 years. Confirmed diagnosis with idiopathic Oligo-Astheno-Teratozoospermia (iOAT) syndrome. Exclusion Criteria: 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
Facility Information:
Facility Name
specialized center of infertility/ Nahrain University
City
Baghdad
ZIP/Postal Code
12221
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All participants demographical and clinical characteristics, and outcome of the study
IPD Sharing Time Frame
Upon publication of the study

Learn more about this trial

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

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