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
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
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
NCT ID
NCT02275169
First Posted
October 21, 2014
Last Updated
January 30, 2015
Sponsor
Azienda Sanitaria Locale Bari
Collaborators
Minia University
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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