FSH Treatment for Non-obstructive Azoospermic Patients

Azoospermia Clinical Trial

Official title:

Follicle-stimulating Hormone Treatment for Infertile Male Patients With Non-obstructive Azoospermia: a Multicenter Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02275169
• Other study ID #: ASLBari
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 21, 2014
• Last updated: January 30, 2015
• Start date: February 2015
• Est. completion date: November 2016

Study information

• Verified date: January 2015
• Source: Azienda Sanitaria Locale Bari
• Contact: Ettore Caroppo, MD
• Phone: +393479103660
• Email: ecaroppo[@]teseo.it
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health, Drug Policy and Planning Center
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Azoospermia

Intervention

Drug:
• Urofollitropin
Urofollitropin 75 IU 2 ampoules three times a week for three months

Other:
• Placebo
Placebo ampoules administered three times a week for three months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale Bari	Minia University

References & Publications (5)

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. — View 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/ — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm retrieval rate (SRR)	testicular sperm retrieval rate after three months of urofollitropin treatment	three months	No
Secondary	IVF pregnancy rate		three to six months	No
Secondary	IVF implantation rate		three to six months	No