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FSH Treatment for Non-obstructive Azoospermic Patients

Primary Purpose

Azoospermia

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Urofollitropin
Placebo
Sponsored by
Azienda Sanitaria Locale Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Azoospermia focused on measuring follicle stimulating hormone treatment, azoospermia nonobstructive, male infertility, follicle stimulating hormone

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Treated

    Controls

    Arm Description

    Urofollitropin 150 IU ampoules three times a week for three months

    Placebo ampoules three times a week for three months

    Outcomes

    Primary Outcome Measures

    Sperm retrieval rate (SRR)
    testicular sperm retrieval rate after three months of urofollitropin treatment

    Secondary Outcome Measures

    IVF pregnancy rate
    IVF implantation rate

    Full Information

    First Posted
    October 21, 2014
    Last Updated
    January 30, 2015
    Sponsor
    Azienda Sanitaria Locale Bari
    Collaborators
    Minia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02275169
    Brief Title
    FSH Treatment for Non-obstructive Azoospermic Patients
    Official Title
    Follicle-stimulating Hormone Treatment for Infertile Male Patients With Non-obstructive Azoospermia: a Multicenter Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    February 2016 (Anticipated)
    Study Completion Date
    November 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Sanitaria Locale Bari
    Collaborators
    Minia University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Azoospermia
    Keywords
    follicle stimulating hormone treatment, azoospermia nonobstructive, male infertility, follicle stimulating hormone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treated
    Arm Type
    Experimental
    Arm Description
    Urofollitropin 150 IU ampoules three times a week for three months
    Arm Title
    Controls
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo ampoules three times a week for three months
    Intervention Type
    Drug
    Intervention Name(s)
    Urofollitropin
    Other Intervention Name(s)
    Fostimon
    Intervention Description
    Urofollitropin 75 IU 2 ampoules three times a week for three months
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo ampoules administered three times a week for three months
    Primary Outcome Measure Information:
    Title
    Sperm retrieval rate (SRR)
    Description
    testicular sperm retrieval rate after three months of urofollitropin treatment
    Time Frame
    three months
    Secondary Outcome Measure Information:
    Title
    IVF pregnancy rate
    Time Frame
    three to six months
    Title
    IVF implantation rate
    Time Frame
    three to six months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ettore Caroppo, MD
    Phone
    +393479103660
    Email
    ecaroppo@teseo.it
    First Name & Middle Initial & Last Name or Official Title & Degree
    Craig Niederberger, MD
    Phone
    3129969330
    Email
    craignied@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ettore Caroppo, MD
    Organizational Affiliation
    ASL Bari
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Craig Niederberger, MD
    Organizational Affiliation
    University at Illinois at Chicago UIC College of Medicine
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Alayman Hussein, MD
    Organizational Affiliation
    El Minia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18423236
    Citation
    Sussman EM, Chudnovsky A, Niederberger CS. Hormonal evaluation of the infertile male: has it evolved? Urol Clin North Am. 2008 May;35(2):147-55, vii. doi: 10.1016/j.ucl.2008.01.010.
    Results Reference
    background
    PubMed Identifier
    11743304
    Citation
    Schoor RA, Elhanbly S, Niederberger CS, Ross LS. The role of testicular biopsy in the modern management of male infertility. J Urol. 2002 Jan;167(1):197-200.
    Results Reference
    background
    PubMed Identifier
    14667875
    Citation
    Caroppo E, Niederberger C, Vizziello GM, D'Amato G. Recombinant human follicle-stimulating hormone as a pretreatment for idiopathic oligoasthenoteratozoospermic patients undergoing intracytoplasmic sperm injection. Fertil Steril. 2003 Dec;80(6):1398-403. doi: 10.1016/s0015-0282(03)02202-7.
    Results Reference
    result
    PubMed Identifier
    24919724
    Citation
    Kato Y, Shiraishi K, Matsuyama H. Expression of testicular androgen receptor in non-obstructive azoospermia and its change after hormonal therapy. Andrology. 2014 Sep;2(5):734-40. doi: 10.1111/j.2047-2927.2014.00240.x. Epub 2014 Jun 12.
    Results Reference
    result
    PubMed Identifier
    22958644
    Citation
    Hussein A, Ozgok Y, Ross L, Rao P, Niederberger C. Optimization of spermatogenesis-regulating hormones in patients with non-obstructive azoospermia and its impact on sperm retrieval: a multicentre study. BJU Int. 2013 Mar;111(3 Pt B):E110-4. doi: 10.1111/j.1464-410X.2012.11485.x. Epub 2012 Sep 7.
    Results Reference
    result

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    FSH Treatment for Non-obstructive Azoospermic Patients

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