Effect of Letrozole on Seminal Parameters in Men With Non Obstructive Azoospermia and Severe Oligozoospermia.
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|ClinicalTrials.gov Identifier: NCT02900105|
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : August 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Azoospermia, Nonobstructive Oligozoospermia||Drug: Letrozole||Phase 3|
This is a pilot study with recruitment carried out in a single centre where participants will be assigned to receive Letrozole 2.5 mg once a day for 4 months. The following data will be collected: semen analyses, clinical history including smoking status, BMI, Y microdeletion, karyotype and FSH, LH, testosterone, E2, drug side effects and effects on libido. The following assessments will be performed before and 4 months after drug administration: sperm analyses, FSH, LH, E2 and testosterone measurements.
Prior to recruitment, the study participant would have undergone the routine investigations for evaluating azoospermia or severe oligozoospermia. These would include FSH, LH, testosterone, karyotyping, Y chromosome microdeletion genetic studies and at least 1 seminal analysis. Despite the availability of biochemical techniques to differentiate non-obstructive azoospermia (NOA) patients from obstructive azoospermia patients, fine needle aspiration (FNA) has been regarded as a highly informative and a minimally invasive method often routinely done in the investigation of azoospermia. All patients with NOA would have a FNA performed as part of their routine workup which would be done before recruitment and initiation of Letrozole. The safety of FNA use is also regarded as being supportive for the researchers against any possible patient lawsuits resulting from any impaired spermatogenesis induced by an off-label prescription. All oligozoospermic patients will be offered to have their sperm cryopreserved before drug administration. The investigations must have been performed within a 6 month time frame prior to recruitment.
There will be 3 clinic visits during the dosing period and 1 post dosing follow up visit. During the initial visit where recruitment into the study occurs, the participant will be prescribed the medication. One week later, a telephone interview will be conducted to review for side effects and arrange an early appointment at patient request. One month later, the participant will be reviewed in clinic and a side effect check list will be conducted. Telephone interviews will be conducted again at 2nd and 3rd month from administration of the drug. At 4th month from administration of the drug, the blood tests and semen analysis will be performed. It is likely that the participant will still be followed up for enrolment into IVF / ICSI programme should spontaneous pregnancy fail to occur. The window period for all clinic visits and telephone interviews is +/- 5 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Letrozole on Seminal Parameters in Men With Non Obstructive Azoospermia and Severe Oligozoospermia.|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Participants will be assigned to receive Letrozole 2.5 mg once a day for 4 months
Letrozole 2.5mg (1 tablet) once a day for 4 months
- Sperm density [ Time Frame: After 4 months dosage of Letrozole ]
- Sperm motility [ Time Frame: After 4 months dosage of Letrozole ]
- Total serum Testosterone level [ Time Frame: After 4 months dosage of Letrozole ]
- Total serum Estradiol level [ Time Frame: After 4 months dosage of Letrozole ]
- Total serum Follicle Stimulating Hormone level [ Time Frame: After 4 months dosage of Letrozole ]
- Total serum Luteinizing Hormone level [ Time Frame: After 4 months dosage of Letrozole ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900105
|KK Women's and Children's Hospital|
|Singapore, Singapore, 229899|
|Principal Investigator:||Shuling Liu||KK Women's and Children's Hospital|