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

Al-Mustansiriyah University

Status and phase: Completed; Phase 2

Conditions: Male Reproductive Problem; Infertility, Male

Treatments: Drug: Letrozole tablets; Dietary Supplement: Coenzyme Q10 table

Study type: Interventional

Funder types: Other

Identifiers

NCT05847257

2023M01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Group A

Sham Comparator group

Description:

group A (29) patients received letrozole 2.5mg twice weekly for 3 months

Treatment:

Drug: Letrozole tablets

Group B

Experimental group

Description:

Group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months

Treatment:

Dietary Supplement: Coenzyme Q10 table

Drug: Letrozole tablets