Clinical Trial: Effect of Letrozole on Seminal Parameters in Men With Non Obstructive Azoospermia and Severe Oligozoospermia.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Letrozole on Seminal Parameters in Men With Non Obstructive Azoospermia and Severe Oligozoospermia.

Brief Summary: The investigators hope to learn if Letrozole is effective and safe in improving severe male infertility by increasing testosterone, decreasing oestradiol and stimulating sperm production thereby improving sperm motility (movement) and concentration. The study is being conducted because Letrozole is not yet proven to be a standard treatment in subjects with absent or very low sperm counts. The investigators are hoping to determine whether Letrozole is equal or superior to no treatment.

Detailed Summary:

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.
Sponsor: KK Women's and Children's Hospital

Current Primary Outcome:

  • Sperm density [ Time Frame: After 4 months dosage of Letrozole ]
  • Sperm motility [ Time Frame: After 4 months dosage of Letrozole ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: KK Women's and Children's Hospital

Dates:
Date Received: August 30, 2016
Date Started: February 2015
Date Completion:
Last Updated: September 8, 2016
Last Verified: September 2016