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

Infertility, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05847257
• Other study ID #: 2023M01
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: April 2023
• Source: Al-Mustansiriyah University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Reproductive Problem

Intervention

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

Locations

Country	Name	City	State
Iraq	specialized center of infertility/ Nahrain University	Baghdad

Sponsors (2)

Lead Sponsor	Collaborator
Al-Mustansiriyah University	Al-Nahrain University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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