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

Phase 2

Completed

• Conditions: Male Reproductive Problem; Infertility, Male
• Interventions: Drug: Letrozole tablets; Dietary Supplement: Coenzyme Q10 table

• Registration Number: NCT05847257
• Lead Sponsor: Al-Mustansiriyah University

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.

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-05-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-15
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Coenzyme Q10 table	Group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months
Group A	Letrozole tablets	group A (29) patients received letrozole 2.5mg twice weekly for 3 months
Group B	Letrozole tablets	Group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

specialized center of infertility/ Nahrain University; 🇮🇶 Baghdad, Iraq