Male InfertilityNAZOSPERMNCT05203211
Use of Testicular Spermatozoa in Non-azoospermic Patients
An observational study of Male Infertility, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Use of testicular spermatozoa in non-azoospermic patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- Testicular sperm extraction (TESE)
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 2 Apr 2022
- Phase
- Observational
- 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
Study population: All couples in a third-level University affiliated centre, between January 2010 and January 2020, whose male partner were diagnosed with any type of oligospermia and underwent TESE after ICSI from ejaculated semen, were included in the analysis.
Who may be able to join
- All patients undergone testiscular sperm extraction (TESE) after failure of ICSI with the use of ejaculated sperm
Who cannot join
- Female age >40 yo
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Paolo Emanuele Levi Setti, MD, 0282241, paolo.levi_setti@humanitas.it
About this study
Official title: Use of Testicular Spermatozoa in Non-azoospermic Patients: Retrospective Analysis of a Single Center Experience.
Use of testicular spermatozoa in non-azoospermic patients.
Read the detailed description
The aim of the study is to evaluate the characteristics of couples whose male partner is offered TESE after the failure of previous ICSI technique performed with ejaculated semen. All couples in a third-level University affiliated centre, between January 2010 and January 2020, whose male partner were diagnosed with any type of oligospermia and underwent TESE after ICSI from ejaculated semen, were included in the analysis.
- Conditions
- Male Infertility
- Being tested
- Testicular sperm extraction (TESE)
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testicular sperm extraction (TESE)Procedure or surgery
During the procedure, the testis is exposed through a small incision and one or more biopsies are taken blindly. A vertical incision is made in the median raphe, skin, dartos and tunica vaginalis to expose tunica albuginea. The tunica albuginea is incised for about 4 mm at upper pole near the head of epididymis.
| Study group | Role | What they receive |
|---|---|---|
| Men who have undergone icsi from ejaculated semen | Not described | |
| Men who have undergone icsi from testicular sperm | Not described Receives: Procedure: Testicular sperm extraction (TESE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fertilization rate (FR)
Evaluate if there is a higher fertilization rate in male patients undergone TESE
Measured: 10 years
Secondary outcomes (2)
Blastulation rate (BR)
Evaluate if there is a higher blastulation rate in male patients undergone TESE
Measured: 10 years
Miscarriage rate (MR)
Evaluate if there is a lower miscarriage rate in male patients undergone TESE
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Mar 2022 (estimated)
- Study completion2 Apr 2022 (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 Male InfertilityStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203211
- Sponsor's protocol ID
- XXX/2022
- Acronym
- NAZOSPERM
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozmen B, Caglar GS, Koster F, Schopper B, Diedrich K, Al-Hasani S. Relationship between sperm DNA damage, induced acrosome reaction and viability in ICSI patients. Reprod Biomed Online. 2007 Aug;15(2):208-14. doi: 10.1016/s1472-6483(10)60710-9.
PubMed 17697499Samplaski MK, Dimitromanolakis A, Lo KC, Grober ED, Mullen B, Garbens A, Jarvi KA. The relationship between sperm viability and DNA fragmentation rates. Reprod Biol Endocrinol. 2015 May 14;13:42. doi: 10.1186/s12958-015-0035-y.
PubMed 25971317Kendall Rauchfuss LM, Kim T, Bleess JL, Ziegelmann MJ, Shenoy CC. Testicular sperm extraction vs. ejaculated sperm use for nonazoospermic male factor infertility. Fertil Steril. 2021 Oct;116(4):963-970. doi: 10.1016/j.fertnstert.2021.05.087. Epub 2021 Jul 4.
PubMed 34233843Donoso P, Tournaye H, Devroey P. Which is the best sperm retrieval technique for non-obstructive azoospermia? A systematic review. Hum Reprod Update. 2007 Nov-Dec;13(6):539-49. doi: 10.1093/humupd/dmm029. Epub 2007 Sep 24.
PubMed 17895238Kang YN, Hsiao YW, Chen CY, Wu CC. Testicular sperm is superior to ejaculated sperm for ICSI in cryptozoospermia: An update systematic review and meta-analysis. Sci Rep. 2018 May 18;8(1):7874. doi: 10.1038/s41598-018-26280-0.
PubMed 29777145
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Testicular Spermatozoa in Non-azoospermic Patients: Retrospective Analysis of a Single Center Experience.
- ClinicalTrials.gov ID
- NCT05203211
- Acronym / sponsor ID
- NAZOSPERM / XXX/2022
- Conditions
- Male Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 2 Apr 2022 (estimated)
- First posted
- 24 Jan 2022 (actual)
- 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.
Use of testicular spermatozoa in non-azoospermic patients.
Detailed description
The aim of the study is to evaluate the characteristics of couples whose male partner is offered TESE after the failure of previous ICSI technique performed with ejaculated semen. All couples in a third-level University affiliated centre, between January 2010 and January 2020, whose male partner were diagnosed with any type of oligospermia and underwent TESE after ICSI from ejaculated semen, were included in the analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men who have undergone icsi from ejaculated semen | – | – |
| Men who have undergone icsi from testicular sperm | – | Procedure: Testicular sperm extraction (TESE) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All couples in a third-level University affiliated centre, between January 2010 and January 2020, whose male partner were diagnosed with any type of oligospermia and underwent TESE after ICSI from ejaculated semen, were included in the analysis.
Key inclusion criteria (1 listed)
- All patients undergone testiscular sperm extraction (TESE) after failure of ICSI with the use of ejaculated sperm
Key exclusion criteria (1 listed)
- Female age >40 yo
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 |
|---|---|---|
| Testicular sperm extraction (TESE)During the procedure, the testis is exposed through a small incision and one or more biopsies are taken blindly. A vertical incision is made in the median raphe, skin, dartos and tunica vaginalis to expose tunica albuginea. The tunica albuginea is incised for about 4 mm at upper pole near the head of epididymis. | Procedure or surgery | Men who have undergone icsi from testicular sperm |
Primary outcome
fertilization rate (FR)
Time frame: 10 years
Evaluate if there is a higher fertilization rate in male patients undergone TESE
2 secondary outcomes
Blastulation rate (BR)
Time frame: 10 years
Miscarriage rate (MR)
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Background: PubMed 17697499Ozmen B, Caglar GS, Koster F, Schopper B, Diedrich K, Al-Hasani S. Relationship between sperm DNA damage, induced acrosome reaction and viability in ICSI patients. Reprod Biomed Online. 2007 Aug;15(2):208-14. doi: 10.1016/s1472-6483(10)60710-9.
- Background: PubMed 25971317Samplaski MK, Dimitromanolakis A, Lo KC, Grober ED, Mullen B, Garbens A, Jarvi KA. The relationship between sperm viability and DNA fragmentation rates. Reprod Biol Endocrinol. 2015 May 14;13:42. doi: 10.1186/s12958-015-0035-y.
- Background: PubMed 34233843Kendall Rauchfuss LM, Kim T, Bleess JL, Ziegelmann MJ, Shenoy CC. Testicular sperm extraction vs. ejaculated sperm use for nonazoospermic male factor infertility. Fertil Steril. 2021 Oct;116(4):963-970. doi: 10.1016/j.fertnstert.2021.05.087. Epub 2021 Jul 4.
- Background: PubMed 17895238Donoso P, Tournaye H, Devroey P. Which is the best sperm retrieval technique for non-obstructive azoospermia? A systematic review. Hum Reprod Update. 2007 Nov-Dec;13(6):539-49. doi: 10.1093/humupd/dmm029. Epub 2007 Sep 24.
- Background: PubMed 29777145Kang YN, Hsiao YW, Chen CY, Wu CC. Testicular sperm is superior to ejaculated sperm for ICSI in cryptozoospermia: An update systematic review and meta-analysis. Sci Rep. 2018 May 18;8(1):7874. doi: 10.1038/s41598-018-26280-0.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, run by Istituto Clinico Humanitas at 1 site in Italy.
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 1 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 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fertilization rate (FR) (time frame: 10 years). 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 NCT05203211, 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 24 Jan 2022.