FSH Treatment for Non-obstructive Azoospermic Patients

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02275169

Enrollment

200

Registered

2014-10-27

Start date

2015-02-28

Completion date

2016-11-30

Last updated

2015-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Azoospermia

Keywords

follicle stimulating hormone treatment, azoospermia nonobstructive, male infertility, follicle stimulating hormone

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.

Interventions

DRUGUrofollitropin

Urofollitropin 75 IU 2 ampoules three times a week for three months

OTHERPlacebo

Placebo ampoules administered three times a week for three months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Sperm retrieval rate (SRR)	three months	testicular sperm retrieval rate after three months of urofollitropin treatment

Secondary

Measure	Time frame
IVF pregnancy rate	three to six months
IVF implantation rate	three to six months

Contacts

Primary ContactEttore Caroppo, MD

ecaroppo@teseo.it+393479103660

Backup ContactCraig Niederberger, MD

craignied@gmail.com3129969330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026