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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
Sponsor:
Information provided by (Responsible Party):
Liu Shuling, KK Women's and Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Azoospermia, Nonobstructive Oligozoospermia Drug: Letrozole Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: Letrozole
Participants will be assigned to receive Letrozole 2.5 mg once a day for 4 months
Drug: Letrozole
Letrozole 2.5mg (1 tablet) once a day for 4 months




Primary Outcome Measures :
  1. Sperm density [ Time Frame: After 4 months dosage of Letrozole ]
  2. Sperm motility [ Time Frame: After 4 months dosage of Letrozole ]

Secondary Outcome Measures :
  1. Total serum Testosterone level [ Time Frame: After 4 months dosage of Letrozole ]
  2. Total serum Estradiol level [ Time Frame: After 4 months dosage of Letrozole ]
  3. Total serum Follicle Stimulating Hormone level [ Time Frame: After 4 months dosage of Letrozole ]
  4. Total serum Luteinizing Hormone level [ Time Frame: After 4 months dosage of Letrozole ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

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


Locations
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Singapore
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
Investigators
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Principal Investigator: Shuling Liu KK Women's and Children's Hospital

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Responsible Party: Liu Shuling, Associate Consultant, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02900105     History of Changes
Other Study ID Numbers: 2014/123/D
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Azoospermia
Oligospermia
Infertility, Male
Infertility
Genital Diseases, Male
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs