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

NCT02900105 | Completed Phase 3

• 1 other identifier: 2014/123/D
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Azoospermia, Nonobstructive; Oligozoospermia

Outcome Measures

Primary Outcomes (2)

• Sperm density

  After 4 months dosage of Letrozole

• Sperm motility

  After 4 months dosage of Letrozole

Secondary Outcomes (4)

• Total serum Testosterone level

  After 4 months dosage of Letrozole

• Total serum Estradiol level

  After 4 months dosage of Letrozole

• Total serum Follicle Stimulating Hormone level

  After 4 months dosage of Letrozole

• Total serum Luteinizing Hormone level

  After 4 months dosage of Letrozole

Study Arms (1)

Letrozole

EXPERIMENTAL

Participants will be assigned to receive Letrozole 2.5 mg once a day for 4 months

Drug: Letrozole

Interventions

Letrozole DRUG

Letrozole 2.5mg (1 tablet) once a day for 4 months

Letrozole

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Azoospermia, Nonobstructive; Oligospermia

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shuling Liu

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 14, 2016
• Study Start: February 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

SG (1)