Infertility, MalePhase 4NCT02719093
Role of FSHR Polymorphism p.N680S in the Therapy With FSH in Patients Who Underwent Varicocele Surgery
A Phase 4 study testing recombinant FSH in people with Infertility, Male and Varicocele, run by U.O. Chirurgia Andrologica.
Trial summary
Two common SNPs are located in linkage disequilibrium in exon 10 of FSHR. The 2039 A>G variant is regularly analyzed to characterize the exon 10 haplotype. In the last years, it has been showed an influence of FSHR 2039 A>G on FSH levels, testicular volume, sperm concentration and the total sperm count. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Infertility, Male, Varicocele
- What is being tested?
- recombinant FSH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2017
- Phase
- Phase 4
- 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 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- OligoAstenoTeratozoospemic patient: Spermatozoa < 15 x 106/ml, Motility < 32%, <4% normal forms
Who cannot join
- Medications and psychoactive or anabolic drugs in last six months.
- Alcohol abuse in last three months.
- Systemic disease(liver cirrhosis, renal failure or others).
- Exposure to pelvic radiation, cytotoxic agent or exposure to environmental toxins.
- Testicular dysgenesis, cryptorchidism or genetic abnormalities (karyotype, Y-chromosome deletions)
- No trauma, testicular torsion, previous orchitis, previous testicular tumors, surgery that can compromise vascularisation of the testes and lead to testicular atrophy, cryptorchidism or genitourinary infection in last one year.
Trial locations and contacts
No sites are listed yet.
About this study
Two common SNPs are located in linkage disequilibrium in exon 10 of FSHR. The 2039 A>G variant is regularly analyzed to characterize the exon 10 haplotype. In the last years, it has been showed an influence of FSHR 2039 A>G on FSH levels, testicular volume, sperm concentration and the total sperm count. A recent Cochrane review showed a beneficial effect on live birth and pregnancy of gonadotrophin treatment for men with idiopathic male factor subfertility. Which FSHR polymorphism can benefit from FSH treatment is clinically very important, in particular for what regards nonidiopathic patients. In many andrological units, patients underwent adiuvant therapy with purified or recombinant FSH after varicocelectomy. FSH treatment in patients after varicocelectomy could improve spermatogenesis, but there aren't multicentric trials that confirm its validity. Usually, in our hospital only patients with a morphologic aspect of hypospermatogenesis underwent therapy with purified or recombinant FSH, because this therapy is not much useful in patient with Partial Sertoli-cell-only syndrome or maturation arrest. The purpose of our study is to correlate "non responder" patients who underwent FSH adiuvant therapy after varicocele surgery with a p.N680S FSHR polymorphism. Moreover the investigators suppose that "non responder" patients can beneficiate from a high-dose therapy with FSH. This is a prospective intervention study in which are recruited males with OligoAstenoTeratozoospermic (OAT) and varicocele. The partecipants will undergo subinguinal microsurgical varicocelectomy (Marmar technique) and needle aspiration testicular cytology (Foresta technique).
Read the detailed description
Two common SNPs (c.919 A>G, pT307A, rs 6165 and c.2039 A>G, p.N680S, rs6166) are located in linkage disequilibrium in exon 10 of FSHR. The 2039 A>G variant is regularly analyzed to characterize the exon 10 haplotype.
It is well known that follice-stimulating hormone (FSH) receptor (FSHR) polymorphism p.N680S mediates different responses to FSH in vitro, and this polymorphism is associated with the ovarian response in controlled ovarian hyperstimulation. In the last years, FSHR gene polymorphisms have been studied as potential risk factors for spermatogenetic failure. It is shown an influence of FSHR 2039 A>G on FSH levels and testicular volume. Trends of higher FSH and lower testicular volume were observed in G-allele carriers (Ala307/Ser680). Men homozygous for Thr307/Asn680 had a lower mean serum FSH concentration compared with men with other genotypes. In addition, sperm concentrations and the total sperm counts were higher and their testes volumes were larger. Another clinical study showed that the patients with heterozygous Thr/Ala + Asn/Ser combined genotype were 2.65 times more susceptible to infertility than the control group. It is also shown the higher sensitivity of the receptor in FSHR 2039 A>G AA homozygotes1-2. A recent Cochrane review showed a beneficial effect on live birth and pregnancy of gonadotrophin treatment for men with idiopathic male factor subfertility. These study suggest that the analysis of this gene represents a valid pharmacogenetic approach to the treatment of male infertility, confirming also the importance of strict criteria for the selection of patients to be treated with FSH. Which FSHR polymorphism can benefit from FSH treatment is clinically very important, in particular for what regards nonidiopathic patients. It is also relevant from a pharmacoeconomic point of view. In many andrological units, patients underwent adiuvant therapy with purified or recombinant FSH after varicocelectomy. FSH treatment in patients after varicocelectomy could improve spermatogenesis, but there aren't multicentric trials that confirm its validity. Usually, in our hospital only patients with a morphologic aspect of hypospermatogenesis underwent therapy with purified or recombinant FSH, because this therapy is not much useful in patient with Partial Sertoli-cell-only syndrome or maturation arrest. The purpose of our study is to correlate "non responder" patients who underwent FSH adiuvant therapy after varicocele surgery with a p.N680S FSHR polymorphism. Moreover the investigators suppose that "non responder" patients can beneficiate from a high-dose therapy with FSH.
This is a prospective intervention study in which are recruited males with OligoAstenoTeratozoospermic (OAT) and varicocele. The partecipants will undergo subinguinal microsurgical varicocelectomy (Marmar technique) and needle aspiration testicular cytology (Foresta technique). One-hundred patients with a morphologic aspect of hypospermatogenesis at testicular cytology will take recombinant follitropin alfa 150UI i.m. 3 times/week for at least three month. At 3th month the partecipants will have a semen analyses, without interrupting the treatment, and the FSHR gene polymorphism p.N680S characterization with PCR in high resolution melting HRM from DNA extracted by a simple blood sample. Patients who will have a significative increase in at least two parameters of semen, will be considered "responders" while patients in which semen parameters will not improve or worsen will be considered "non responders". "Responders" patients will interrupt their therapy and will have a new semen analyses at six month to verify the maintenance of their semen parameters after only three months of therapy. "Non responders" patients will take a daily dose of rFSH 150 UI for additional three months, because the investigators suppose that men with specific polymorphisms who don't response to therapy need an higher dose to stimulate spermatogenesis and to have a spontaneous pregnancy. At 6th month also these patients will have a new semen analyses in order to verify if there are some improvements in their spermatogenesis.
- Conditions
- Infertility, Male, Varicocele
- Being tested
- recombinant FSH
- Keywords
- Infertility Male, Receptors FSH, Varicocele, FSH therapy
- Medical subject headings
- Infertility, Male, Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant FSHDrug
Also called Puregon, Gonal-F
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| recombinant FSH | Experimental | recombinant FSH 150UI daily Receives: Drug: recombinant FSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sperm count
Response to therapy indicated by significant increase in sperm count (million/ejaculate) according to WHO Laboratory Manual for the Examination and Processing of Human Semen (5th edn.)
Measured: After subinguinal microsurgical varicocelectomy and therapy with recombinant follitropin alfa 150UI i.m. 3 times/week for three months
Sperm concentration
Response to therapy indicated by significant increase in sperm concentration (million/mL) according to WHO Laboratory Manual for the Examination and Processing of Human Semen (5th edn.)
Measured: After subinguinal microsurgical varicocelectomy and therapy with recombinant follitropin alfa 150UI i.m. 3 times/week for three months
Total motility
Response to therapy indicated by significant increase in total motility (%) according to WHO Laboratory Manual for the Examination and
Measured: After subinguinal microsurgical varicocelectomy and therapy with recombinant follitropin alfa 150UI i.m. 3 times/week for three months
Progressive motility
Response to therapy indicated by significant increase in progressive motility (%) according to WHO Laboratory Manual for the Examination and
Measured: After subinguinal microsurgical varicocelectomy and therapy with recombinant follitropin alfa 150UI i.m. 3 times/week for three months
Sperm morphology (normal forms)
Response to therapy indicated by significant increase in sperm morphology (normal forms) (%) according to WHO Laboratory Manual for the Examination and
Measured: After subinguinal microsurgical varicocelectomy and therapy with recombinant follitropin alfa 150UI i.m. 3 times/week for three months
Secondary outcomes (5)
Total sperm count
Response to therapy indicated by significant increase in sperm count (million/ejaculate) according to WHO Laboratory Manual for the Examination and
Measured: After a daily dose of rFSH 150 UI for additional three months in "non responders" patients to the first three months of therapy with recombinant follitropin alfa 150UI i.m. 3 times/week
Sperm concentration
Response to therapy indicated by significant increase in sperm concentration (million/mL) according to WHO Laboratory Manual for the Examination and
Measured: After a daily dose of rFSH 150 UI for additional three months in "non responders" patients to the first three months of therapy with recombinant follitropin alfa 150UI i.m. 3 times/week
Total motility
Response to therapy indicated by significant increase in total motility (%) according to WHO Laboratory Manual for the Examination and
Measured: After a daily dose of rFSH 150 UI for additional three months in "non responders" patients to the first three months of therapy with recombinant follitropin alfa 150UI i.m. 3 times/week
Progressive motility
Response to therapy indicated by significant increase in progressive motility (%) according to WHO Laboratory Manual for the Examination and
Measured: After a daily dose of rFSH 150 UI for additional three months in "non responders" patients to the first three months of therapy with recombinant follitropin alfa 150UI i.m. 3 times/week
Sperm morphology (normal forms)
Response to therapy indicated by significant increase in sperm morphology (normal forms) (%) according to WHO Laboratory Manual for the Examination and
Measured: After a daily dose of rFSH 150 UI for additional three months in "non responders" patients to the first three months of therapy with recombinant follitropin alfa 150UI i.m. 3 times/week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infertility, MaleStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.O. Chirurgia Andrologica
- Sponsor type
- University, hospital or other
- Collaborators
- Androcenter, Napoli, Italy
- Responsible party
- Principal investigator, Maurizio Carrino, U.O. Chirurgia Andrologica
- Investigators
- Maurizio Carrino, Study director, AORN A.CARDARELLI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719093
- Sponsor's protocol ID
- CHIRURGIAANDROLOGICA-1
- Status last verified
- Mar 2016
- First submitted
- 12 Dec 2015
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tuttelmann F, Laan M, Grigorova M, Punab M, Sober S, Gromoll J. Combined effects of the variants FSHB -211G>T and FSHR 2039A>G on male reproductive parameters. J Clin Endocrinol Metab. 2012 Oct;97(10):3639-47. doi: 10.1210/jc.2012-1761. Epub 2012 Jul 12.
PubMed 22791757Casarini L, Moriondo V, Marino M, Adversi F, Capodanno F, Grisolia C, La Marca A, La Sala GB, Simoni M. FSHR polymorphism p.N680S mediates different responses to FSH in vitro. Mol Cell Endocrinol. 2014 Aug 5;393(1-2):83-91. doi: 10.1016/j.mce.2014.06.013. Epub 2014 Jun 23.
PubMed 24970684
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of FSHR Polymorphism p.N680S in the Therapy With FSH in Patients Who Underwent Varicocele Surgery
- ClinicalTrials.gov ID
- NCT02719093
- Acronym / sponsor ID
- CHIRURGIAANDROLOGICA-1
- Conditions
- Infertility, Male, Varicocele
- Keywords
- Infertility Male, Receptors FSH, Varicocele, FSH therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- U.O. Chirurgia AndrologicaUniversity, hospital or other
- Collaborators
- Androcenter, Napoli, Italy
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Mar 2016 (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.
Two common SNPs are located in linkage disequilibrium in exon 10 of FSHR. The 2039 A>G variant is regularly analyzed to characterize the exon 10 haplotype. In the last years, it has been showed an influence of FSHR 2039 A>G on FSH levels, testicular volume, sperm concentration and the total sperm count. A recent Cochrane review showed a beneficial effect on live birth and pregnancy of gonadotrophin treatment for men with idiopathic male factor subfertility. Which FSHR polymorphism can benefit from FSH treatment is clinically very important, in particular for what regards nonidiopathic patients. In many andrological units, patients underwent adiuvant therapy with purified or recombinant FSH after varicocelectomy. FSH treatment in patients after varicocelectomy could improve spermatogenesis, but there aren't multicentric trials that confirm its validity. Usually, in our hospital only patients with a morphologic aspect of hypospermatogenesis underwent therapy with purified or recombinant FSH, because this therapy is not much useful in patient with Partial Sertoli-cell-only syndrome or maturation arrest. The purpose of our study is to correlate "non responder" patients who underwent FSH adiuvant therapy after varicocele surgery with a p.N680S FSHR polymorphism. Moreover the investigators suppose that "non responder" patients can beneficiate from a high-dose therapy with FSH. This is a prospective intervention study in which are recruited males with OligoAstenoTeratozoospermic (OAT) and varicocele. The partecipants will undergo subinguinal microsurgical varicocelectomy (Marmar technique) and needle aspiration testicular cytology (Foresta technique).
Detailed description
Two common SNPs (c.919 A>G, pT307A, rs 6165 and c.2039 A>G, p.N680S, rs6166) are located in linkage disequilibrium in exon 10 of FSHR. The 2039 A>G variant is regularly analyzed to characterize the exon 10 haplotype.
It is well known that follice-stimulating hormone (FSH) receptor (FSHR) polymorphism p.N680S mediates different responses to FSH in vitro, and this polymorphism is associated with the ovarian response in controlled ovarian hyperstimulation. In the last years, FSHR gene polymorphisms have been studied as potential risk factors for spermatogenetic failure. It is shown an influence of FSHR 2039 A>G on FSH levels and testicular volume. Trends of higher FSH and lower testicular volume were observed in G-allele carriers (Ala307/Ser680). Men homozygous for Thr307/Asn680 had a lower mean serum FSH concentration compared with men with other genotypes. In addition, sperm concentrations and the total sperm counts were higher and their testes volumes were larger. Another clinical study showed that the patients with heterozygous Thr/Ala + Asn/Ser combined genotype were 2.65 times more susceptible to infertility than the control group. It is also shown the higher sensitivity of the receptor in FSHR 2039 A>G AA homozygotes1-2. A recent Cochrane review showed a beneficial effect on live birth and pregnancy of gonadotrophin treatment for men with idiopathic male factor subfertility. These study suggest that the analysis of this gene represents a valid pharmacogenetic approach to the treatment of male infertility, confirming also the importance of strict criteria for the selection of patients to be treated with FSH. Which FSHR polymorphism can benefit from FSH treatment is clinically very important, in particular for what regards nonidiopathic patients. It is also relevant from a pharmacoeconomic point of view. In many andrological units, patients underwent adiuvant therapy with purified or recombinant FSH after varicocelectomy. FSH treatment in patients after varicocelectomy could improve spermatogenesis, but there aren't multicentric trials that confirm its validity. Usually, in our hospital only patients with a morphologic aspect of hypospermatogenesis underwent therapy with purified or recombinant FSH, because this therapy is not much useful in patient with Partial Sertoli-cell-only syndrome or maturation arrest. The purpose of our study is to correlate "non responder" patients who underwent FSH adiuvant therapy after varicocele surgery with a p.N680S FSHR polymorphism. Moreover the investigators suppose that "non responder" patients can beneficiate from a high-dose therapy with FSH.
This is a prospective intervention study in which are recruited males with OligoAstenoTeratozoospermic (OAT) and varicocele. The partecipants will undergo subinguinal microsurgical varicocelectomy (Marmar technique) and needle aspiration testicular cytology (Foresta technique). One-hundred patients with a morphologic aspect of hypospermatogenesis at testicular cytology will take recombinant follitropin alfa 150UI i.m. 3 times/week for at least three month. At 3th month the partecipants will have a semen analyses, without interrupting the treatment, and the FSHR gene polymorphism p.N680S characterization with PCR in high resolution melting HRM from DNA extracted by a simple blood sample. Patients who will have a significative increase in at least two parameters of semen, will be considered "responders" while patients in which semen parameters will not improve or worsen will be considered "non responders". "Responders" patients will interrupt their therapy and will have a new semen analyses at six month to verify the maintenance of their semen parameters after only three months of therapy. "Non responders" patients will take a daily dose of rFSH 150 UI for additional three months, because the investigators suppose that men with specific polymorphisms who don't response to therapy need an higher dose to stimulate spermatogenesis and to have a spontaneous pregnancy. At 6th month also these patients will have a new semen analyses in order to verify if there are some improvements in their spermatogenesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| recombinant FSH | Experimental | Drug: recombinant FSHrecombinant FSH 150UI daily |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- OligoAstenoTeratozoospemic patient: Spermatozoa < 15 x 106/ml, Motility < 32%, <4% normal forms
Key exclusion criteria (6 listed)
- Medications and psychoactive or anabolic drugs in last six months.
- Alcohol abuse in last three months.
- Systemic disease(liver cirrhosis, renal failure or others).
- Exposure to pelvic radiation, cytotoxic agent or exposure to environmental toxins.
- Testicular dysgenesis, cryptorchidism or genetic abnormalities (karyotype, Y-chromosome deletions)
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 |
|---|---|---|
| recombinant FSHAlso: Puregon, Gonal-FSubcutaneous injection | Drug | recombinant FSH |
Primary outcome
Total sperm count
Time frame: After subinguinal microsurgical varicocelectomy and therapy with recombinant follitropin alfa 150UI i.m. 3 times/week for three months
Response to therapy indicated by significant increase in sperm count (million/ejaculate) according to WHO Laboratory Manual for the Examination and Processing of Human Semen (5th edn.)
Sperm concentration
Time frame: After subinguinal microsurgical varicocelectomy and therapy with recombinant follitropin alfa 150UI i.m. 3 times/week for three months
Response to therapy indicated by significant increase in sperm concentration (million/mL) according to WHO Laboratory Manual for the Examination and Processing of Human Semen (5th edn.)
Total motility
Time frame: After subinguinal microsurgical varicocelectomy and therapy with recombinant follitropin alfa 150UI i.m. 3 times/week for three months
Response to therapy indicated by significant increase in total motility (%) according to WHO Laboratory Manual for the Examination and
Progressive motility
Time frame: After subinguinal microsurgical varicocelectomy and therapy with recombinant follitropin alfa 150UI i.m. 3 times/week for three months
Response to therapy indicated by significant increase in progressive motility (%) according to WHO Laboratory Manual for the Examination and
Sperm morphology (normal forms)
Time frame: After subinguinal microsurgical varicocelectomy and therapy with recombinant follitropin alfa 150UI i.m. 3 times/week for three months
Response to therapy indicated by significant increase in sperm morphology (normal forms) (%) according to WHO Laboratory Manual for the Examination and
5 secondary outcomes
Total sperm count
Time frame: After a daily dose of rFSH 150 UI for additional three months in "non responders" patients to the first three months of therapy with recombinant follitropin alfa 150UI i.m. 3 times/week
Sperm concentration
Time frame: After a daily dose of rFSH 150 UI for additional three months in "non responders" patients to the first three months of therapy with recombinant follitropin alfa 150UI i.m. 3 times/week
Total motility
Time frame: After a daily dose of rFSH 150 UI for additional three months in "non responders" patients to the first three months of therapy with recombinant follitropin alfa 150UI i.m. 3 times/week
Progressive motility
Time frame: After a daily dose of rFSH 150 UI for additional three months in "non responders" patients to the first three months of therapy with recombinant follitropin alfa 150UI i.m. 3 times/week
Sperm morphology (normal forms)
Time frame: After a daily dose of rFSH 150 UI for additional three months in "non responders" patients to the first three months of therapy with recombinant follitropin alfa 150UI i.m. 3 times/week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Results publication: PubMed 22791757Tuttelmann F, Laan M, Grigorova M, Punab M, Sober S, Gromoll J. Combined effects of the variants FSHB -211G>T and FSHR 2039A>G on male reproductive parameters. J Clin Endocrinol Metab. 2012 Oct;97(10):3639-47. doi: 10.1210/jc.2012-1761. Epub 2012 Jul 12.
- Results publication: PubMed 24970684Casarini L, Moriondo V, Marino M, Adversi F, Capodanno F, Grisolia C, La Marca A, La Sala GB, Simoni M. FSHR polymorphism p.N680S mediates different responses to FSH in vitro. Mol Cell Endocrinol. 2014 Aug 5;393(1-2):83-91. doi: 10.1016/j.mce.2014.06.013. Epub 2014 Jun 23.
- Individual participant dataSharing planned: Undecided
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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.
Maurizio Carrino study director
AORN A.CARDARELLI
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing recombinant FSH in people with Infertility, Male and Varicocele, run by U.O. Chirurgia Andrologica.
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 1 inclusion and 6 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 25 Mar 2016. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Maurizio Carrino (+393347967341, cris63@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sperm count (time frame: After subinguinal microsurgical varicocelectomy and therapy with recombinant follitropin alfa 150UI i.m. 3 times/week for three months). The study lists 5 primary outcomes in all. 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 NCT02719093, which also lists 2 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 25 Mar 2016.