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

Study Overview
=================
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.

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

Conditions
-----------------
Male Reproductive Problem, Infertility, Male

Intervention / Treatment
-----------------
* Drug: Letrozole tablets
* Dietary Supplement: Coenzyme Q10 table


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

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 |