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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: KK Women's and Children's Hospital
• Treatments: Letrozole

Criteria

Inclusion Criteria

• Patients with non-obstructive azoospermia (absence of sperm in the pellets of two centrifuged semen samples collected 30-60 days apart)

• Patients with non-obstructive azoospermia who do not yield spermatozoa with fine needle aspiration (FNA)

• Patients with severe oligozoospermia (presence of sperm concentration less than 5 million per ml in both semen samples collected 30-60 days apart)

• Normal sperm appearance, consistency, liquefaction, volume and pH

• Patient must not possess any chromosomal aberrations

Exclusion Criteria

• Possible etiology of infertility present

• Seminal white blood cell concentration more than 10 million per ml

• Positive seminal culture analysis

• Positive urethral swab for chlamydia test

• Smoker

• Drug or alcohol abuse

• Ongoing medical treatment (gonadotropins, anabolic steroids, cancer chemotherapy, non-steroidal anti-inflammatory drugs, previous cancer radiotherapy or chemotherapy)

• Palpable varicocele

• X-ray exposure in the previous 8 months

• Y chromosome microdeletion

• Karyotype abnormalities (Klinefelter syndrome)