Clinical trial NCT05847257: Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram
Official title: Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram and Sex Hormone in Iraqi Infertile Men; A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Male Reproductive Problem
Infertility, Male
Lead sponsor: Al-Mustansiriyah University
Sponsor class: OTHER
Collaborators: name: Al-Nahrain University
First posted: 2023-05-06
Enrollment: 74
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The seminal fluid analysis
timeFrame: change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment
Secondary outcomes:
measure: hormone profile
timeFrame: change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: specialized center of infertility/ Nahrain University
Study officials:
References: