Male Reproductive ProblemPhase 2NCT05847257
Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram
A Phase 2 study testing Letrozole tablets and Coenzyme Q10 table in people with Male Reproductive Problem and Infertility, Male, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Male Reproductive Problem, Infertility, Male
- What is being tested?
- Letrozole tablets and Coenzyme Q10 table
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteIraq
- Study dates
- 1 Dec 2021to 30 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Adult male patients.
- Aged 18 - 60 years.
- Confirmed diagnosis with idiopathic Oligo-Astheno-Teratozoospermia (iOAT) syndrome.
Who cannot join
- Patients who have been found to have additional infertility causes, such as varicocele or Obstruction of the ejaculatory duct.
- Those who have had surgery for male factor infertility.
- Patients with infections such as STD.
- Patient with renal or liver disease
- Incomplete patient data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram and Sex Hormone in Iraqi Infertile Men; A Comparative Study
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.
Read the 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.
- Conditions
- Male Reproductive Problem, Infertility, Male
- Being tested
- Letrozole tablets, Coenzyme Q10 table
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole tabletsDrug
letrozole 2.5mg twice weekly for 3 months
Coenzyme Q10 tableDietary supplement
Coenzyme Q10 400 mg per day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group A | Sham comparator | group A (29) patients received letrozole 2.5mg twice weekly for 3 months Receives: Drug: Letrozole tablets |
| Group B | Experimental | Group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months Receives: Drug: Letrozole tablets; Dietary Supplement: Coenzyme Q10 table |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seminal fluid analysis
sperm volume/ ml, Sperm concentration/ml, Total sperm count / ml, Progressive Sperm motility (%), Non-progressive Sperm motility (%), Immotile Sperm (%), Normal Sperm morphology (%)
Measured: change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment
Secondary outcomes (1)
hormone profile
concentration of Serum FSH, concentration of Serum estradiol, and concentration of Serum testosterone
Measured: change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Dec 2021
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male Reproductive ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Nahrain University
- Responsible party
- Principal investigator, Mohammed Mahmood Mohammed, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847257
- Sponsor's protocol ID
- 2023M01
- Status last verified
- Feb 2025
- First submitted
- 10 Apr 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participants demographical and clinical characteristics, and outcome of the study
Publications
Fadhil EB, Mohammed MM, Alkawaz UM. Impact of coenzyme Q10 as an adjuvant therapy to letrozole on spermiogram results and sex hormone levels in Iraqi men with infertility; randomized open label comparative study. F1000Res. 2024 Jun 10;12:1093. doi: 10.12688/f1000research.131985.3. eCollection 2023.
PubMed 38957201
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram and Sex Hormone in Iraqi Infertile Men; A Comparative Study
- ClinicalTrials.gov ID
- NCT05847257
- Acronym / sponsor ID
- 2023M01
- Conditions
- Male Reproductive Problem, Infertility, Male
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Collaborators
- Al-Nahrain University
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Sham comparator | Drug: Letrozole tabletsgroup A (29) patients received letrozole 2.5mg twice weekly for 3 months |
| Group B | Experimental | Drug: Letrozole tablets, Dietary Supplement: Coenzyme Q10 tableGroup B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult male patients.
- Aged 18 - 60 years.
- Confirmed diagnosis with idiopathic Oligo-Astheno-Teratozoospermia (iOAT) syndrome.
Key exclusion criteria (5 listed)
- Patients who have been found to have additional infertility causes, such as varicocele or Obstruction of the ejaculatory duct.
- Those who have had surgery for male factor infertility.
- Patients with infections such as STD.
- Patient with renal or liver disease
- Incomplete patient data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole tabletsletrozole 2.5mg twice weekly for 3 months | Drug | Group A, Group B |
| Coenzyme Q10 tableCoenzyme Q10 400 mg per day for 3 months | Dietary supplement | Group B |
Primary outcome
The seminal fluid analysis
Time frame: 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 (%)
1 secondary outcome
hormone profile
Time frame: change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Derived from this study: PubMed 38957201Fadhil EB, Mohammed MM, Alkawaz UM. Impact of coenzyme Q10 as an adjuvant therapy to letrozole on spermiogram results and sex hormone levels in Iraqi men with infertility; randomized open label comparative study. F1000Res. 2024 Jun 10;12:1093. doi: 10.12688/f1000research.131985.3. eCollection 2023.
- PublicationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All participants demographical and clinical characteristics, and outcome of the study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole tablets and Coenzyme Q10 table in people with Male Reproductive Problem and Infertility, Male, run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The seminal fluid analysis (time frame: change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05847257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.