AzoospermiaPhase 3NCT02275169
FSH Treatment for Non-obstructive Azoospermic Patients
A Phase 3 study testing Urofollitropin in people with Azoospermia, run by Azienda Sanitaria Locale Bari.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Azoospermia
- What is being tested?
- Urofollitropin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Azoospermia;
- testis longitudinal axis less than 4.5 cm;
- serum follicle-stimulating hormone greater than 7.6 IU/L
Who cannot join
- History of testicular biopsy,
- malignancy,
- varicocele,
- hyperprolactinemia,
- thyroid disfunction,
- chemotherapy,
- radiotherapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Follicle-stimulating Hormone Treatment for Infertile Male Patients With Non-obstructive Azoospermia: a Multicenter Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Azoospermia
- Being tested
- Urofollitropin, Placebo
- Keywords
- follicle stimulating hormone treatment, azoospermia nonobstructive, male infertility, follicle stimulating hormone
- Medical subject headings
- Azoospermia, Azoospermia, Nonobstructive, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrofollitropinDrug
Also called Fostimon
Urofollitropin 75 IU 2 ampoules three times a week for three months
PlaceboOther
Placebo ampoules administered three times a week for three months
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | Urofollitropin 150 IU ampoules three times a week for three months Receives: Drug: Urofollitropin |
| Controls | Placebo comparator | Placebo ampoules three times a week for three months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm retrieval rate (SRR)
testicular sperm retrieval rate after three months of urofollitropin treatment
Measured: three months
Secondary outcomes (2)
IVF pregnancy rate
Measured: three to six months
IVF implantation rate
Measured: three to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AzoospermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University
- Responsible party
- Principal investigator, Ettore Caroppo, Azienda Sanitaria Locale Bari
- Investigators
- Ettore Caroppo, MD, Study director, ASL BariCraig Niederberger, MD, Study chair, University at Illinois at Chicago UIC College of MedicineAlayman Hussein, MD, Principal investigator, El Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275169
- Sponsor's protocol ID
- ASLBari
- Status last verified
- Jan 2015
- First submitted
- 21 Oct 2014
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18423236Schoor 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.
PubMed 11743304Caroppo 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.
PubMed 14667875Kato 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.
PubMed 24919724Hussein 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.
PubMed 22958644
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicle-stimulating Hormone Treatment for Infertile Male Patients With Non-obstructive Azoospermia: a Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02275169
- Acronym / sponsor ID
- ASLBari
- Conditions
- Azoospermia
- Keywords
- follicle stimulating hormone treatment, azoospermia nonobstructive, male infertility, follicle stimulating hormone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale BariUniversity, hospital or other
- Collaborators
- Minia University
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Drug: UrofollitropinUrofollitropin 150 IU ampoules three times a week for three months |
| Controls | Placebo comparator | Other: PlaceboPlacebo ampoules three times a week for three months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Azoospermia;
- testis longitudinal axis less than 4.5 cm;
- serum follicle-stimulating hormone greater than 7.6 IU/L
Key exclusion criteria (7 listed)
- History of testicular biopsy,
- malignancy,
- varicocele,
- hyperprolactinemia,
- thyroid disfunction,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UrofollitropinAlso: FostimonUrofollitropin 75 IU 2 ampoules three times a week for three months | Drug | Treated |
| PlaceboPlacebo ampoules administered three times a week for three months | Other | Controls |
Primary outcome
Sperm retrieval rate (SRR)
Time frame: three months
testicular sperm retrieval rate after three months of urofollitropin treatment
2 secondary outcomes
IVF pregnancy rate
Time frame: three to six months
IVF implantation rate
Time frame: three to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
- Background: PubMed 18423236Sussman 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.
- Background: PubMed 11743304Schoor 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 publication: PubMed 14667875Caroppo 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 publication: PubMed 24919724Kato 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 publication: PubMed 22958644Hussein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ettore Caroppo, MD study director
ASL Bari
Craig Niederberger, MD study chair
University at Illinois at Chicago UIC College of Medicine
Alayman Hussein, MD principal investigator
El Minia University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Urofollitropin in people with Azoospermia, run by Azienda Sanitaria Locale Bari.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ettore Caroppo, MD (+393479103660, ecaroppo@teseo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm retrieval rate (SRR) (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02275169, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2015.