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NCT Number: NCT05847257

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

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.

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Key information

Conditions

Male Reproductive Problem Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

specialized center of infertility/ Nahrain University

Baghdad, 12221, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Letrozole tablets

Drug

letrozole 2.5mg twice weekly for 3 months

Coenzyme Q10 table

Dietary Supplement

Coenzyme Q10 400 mg per day for 3 months

Primary outcomes

  1. The seminal fluid analysis

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

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

Secondary outcomes

  1. hormone profile

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

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

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Collaborators

  • Al-Nahrain University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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