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FSH Treatment for Non-obstructive Azoospermic Patients

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ClinicalTrials.gov Identifier: NCT02275169
Recruitment Status : Unknown
Verified January 2015 by Ettore Caroppo, Azienda Sanitaria Locale Bari.
Recruitment status was:  Not yet recruiting
First Posted : October 27, 2014
Last Update Posted : February 2, 2015
Minia University
Information provided by (Responsible Party):
Ettore Caroppo, Azienda Sanitaria Locale Bari

Brief Summary:
Aim of the study is to evaluate the effect of highly purified human follicle-stimulating hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from infertile male patients with non-obstructive azoospermia of unknown origin.

Condition or disease Intervention/treatment Phase
Azoospermia Drug: Urofollitropin Other: Placebo Phase 3

Detailed Description:
Preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with NOA, but no RCT are available in the field. This randomized placebo-controlled clinical trial sought to evaluate whether the testicular sperm retrieval rate could result higher in NOA patients treated with follicle-stimulating hormone compared to placebo-treated NOA subjects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Follicle-stimulating Hormone Treatment for Infertile Male Patients With Non-obstructive Azoospermia: a Multicenter Randomized Clinical Trial
Study Start Date : February 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: Treated
Urofollitropin 150 IU ampoules three times a week for three months
Drug: Urofollitropin
Urofollitropin 75 IU 2 ampoules three times a week for three months
Other Name: Fostimon

Placebo Comparator: Controls
Placebo ampoules three times a week for three months
Other: Placebo
Placebo ampoules administered three times a week for three months

Primary Outcome Measures :
  1. Sperm retrieval rate (SRR) [ Time Frame: three months ]
    testicular sperm retrieval rate after three months of urofollitropin treatment

Secondary Outcome Measures :
  1. IVF pregnancy rate [ Time Frame: three to six months ]
  2. IVF implantation rate [ Time Frame: three to six months ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Azoospermia;
  • testis longitudinal axis less than 4.5 cm;
  • serum follicle-stimulating hormone greater than 7.6 IU/L

Exclusion Criteria:

  • History of testicular biopsy,
  • malignancy,
  • varicocele,
  • hyperprolactinemia,
  • thyroid disfunction,
  • chemotherapy,
  • radiotherapy

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): NCT02275169

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Contact: Ettore Caroppo, MD +393479103660 ecaroppo@teseo.it
Contact: Craig Niederberger, MD 3129969330 craignied@gmail.com

Sponsors and Collaborators
Azienda Sanitaria Locale Bari
Minia University
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Study Director: Ettore Caroppo, MD ASL Bari
Study Chair: Craig Niederberger, MD University at Illinois at Chicago UIC College of Medicine
Principal Investigator: Alayman Hussein, MD El Minia University
Publications of Results:
Other Publications:
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Responsible Party: Ettore Caroppo, Dr, Azienda Sanitaria Locale Bari
ClinicalTrials.gov Identifier: NCT02275169    
Other Study ID Numbers: ASLBari
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015
Keywords provided by Ettore Caroppo, Azienda Sanitaria Locale Bari:
follicle stimulating hormone treatment
azoospermia nonobstructive
male infertility
follicle stimulating hormone
Additional relevant MeSH terms:
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Infertility, Male