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Clinical trial

Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram and Sex Hormone in Iraqi Infertile Men; A Comparative Study

ID
Name
2023M01
Description
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.
Trial arms
Trial start
2021-12-01
Estimated PCD
2022-10-30
Trial end
2022-10-30
Status
Completed
Phase
Early phase I
Treatment
Letrozole tablets
letrozole 2.5mg twice weekly for 3 months
Arms:
Group A, Group B
Coenzyme Q10 table
Coenzyme Q10 400 mg per day for 3 months
Arms:
Group B
Size
74
Primary endpoint
The seminal fluid analysis
change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nPatients 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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 74, 'type': 'ACTUAL'}}
Updated at
2023-05-06

1 organization

1 product

3 indications

Organization
Al-Mustansiriyah University
Product
Letrozole
Indication
Male Reproductive Problem
Indication
infertility
Indication
male