Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2015-02-28
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treated
Urofollitropin 150 IU ampoules three times a week for three months
Urofollitropin
Urofollitropin 75 IU 2 ampoules three times a week for three months
Controls
Placebo ampoules three times a week for three months
Placebo
Placebo ampoules administered three times a week for three months
Interventions
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Urofollitropin
Urofollitropin 75 IU 2 ampoules three times a week for three months
Placebo
Placebo ampoules administered three times a week for three months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* testis longitudinal axis less than 4.5 cm;
* serum follicle-stimulating hormone greater than 7.6 IU/L
Exclusion Criteria
* malignancy,
* varicocele,
* hyperprolactinemia,
* thyroid disfunction,
* chemotherapy,
* radiotherapy
18 Years
60 Years
MALE
No
Sponsors
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Minia University
OTHER
Azienda Sanitaria Locale Bari
OTHER
Responsible Party
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Ettore Caroppo
Dr
Principal Investigators
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Ettore Caroppo, MD
Role: STUDY_DIRECTOR
ASL Bari
Craig Niederberger, MD
Role: STUDY_CHAIR
University at Illinois at Chicago UIC College of Medicine
Alayman Hussein, MD
Role: PRINCIPAL_INVESTIGATOR
El Minia University
Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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ASLBari
Identifier Type: -
Identifier Source: org_study_id
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