Male Reproductive Problem, Infertility, Male
Conditions
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.
Interventions
letrozole 2.5mg twice weekly for 3 months
DIETARY_SUPPLEMENTCoenzyme Q10 table
Coenzyme Q10 400 mg per day for 3 months
Sponsors
Al-Nahrain University
Al-Mustansiriyah University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The seminal fluid analysis | 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
| Measure | Time frame | Description |
|---|---|---|
| hormone profile | 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 |
Countries
Iraq
Outcome results
None listed