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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-10-30

Brief Summary

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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.

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Detailed Description

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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

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Male Reproductive Problem Infertility, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type SHAM_COMPARATOR

Letrozole tablets

Intervention Type DRUG

letrozole 2.5mg twice weekly for 3 months

Group B

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

Group Type EXPERIMENTAL

Letrozole tablets

Intervention Type DRUG

letrozole 2.5mg twice weekly for 3 months

Coenzyme Q10 table

Intervention Type DIETARY_SUPPLEMENT

Coenzyme Q10 400 mg per day for 3 months

Interventions

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Letrozole tablets

letrozole 2.5mg twice weekly for 3 months

Intervention Type DRUG

Coenzyme Q10 table

Coenzyme Q10 400 mg per day for 3 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Mohammed Mahmood Mohammed

Clinical associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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specialized center of infertility/ Nahrain University

Baghdad, , Iraq

Site Status

Countries

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Iraq

References

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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.

Reference Type DERIVED

PMID: 38957201 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

data of 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

View Document