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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05847257
Other study ID # 2023M01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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