Clinical trial NCT02275169: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Azoospermia
Keywords: follicle stimulating hormone treatment
azoospermia nonobstructive
male infertility
follicle stimulating hormone
Lead sponsor: Azienda Sanitaria Locale Bari
Sponsor class: OTHER
Collaborators: name: Minia University
First posted: 2014-10-27
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sperm retrieval rate (SRR)
timeFrame: three months
Secondary outcomes:
measure: IVF pregnancy rate
timeFrame: three to six months
measure: IVF implantation rate
timeFrame: three to six months
Other outcomes:
Locations:
Study officials:
affiliation: ASL Bari
name: Ettore Caroppo, MD
role: STUDY_DIRECTOR
affiliation: University at Illinois at Chicago UIC College of Medicine
name: Craig Niederberger, MD
role: STUDY_CHAIR
affiliation: El Minia University
name: Alayman Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.