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

• Sponsor: Al-Mustansiriyah University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05847257
• Collaborator: Al-Nahrain University (Other)
• Enrollment: 74
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.9
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Male Reproductive Problem; Infertility, Male	Drug: Letrozole tablets; Dietary Supplement: Coenzyme Q10 table	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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)
• Primary Purpose: Treatment
• Official Title: Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram and Sex Hormone in Iraqi Infertile Men; A Comparative Study
• Actual Study Start Date: Dec 1, 2021
• Actual Primary Completion Date: Oct 30, 2022
• Actual Study Completion Date: Oct 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	specialized center of infertility/ Nahrain University	Baghdad		Iraq	12221

Sponsors and Collaborators

• Al-Mustansiriyah University
• Al-Nahrain University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammed Mahmood Mohammed, Clinical associated professor, Al-Mustansiriyah University
• ClinicalTrials.gov Identifier: NCT05847257
• Other Study ID Numbers: 2023M01
• First Posted: May 6, 2023
• Last Update Posted: May 6, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Infertility, Male; Ubiquinone; Coenzyme Q10; Letrozole

Study Results

No Results Posted as of May 6, 2023