Klinefelter SyndromeFERTIPRESERVENCT01918280
Fertility Preservation in Cases of Klinefelter Syndrome.
A study testing Seminal analyses and testicular biopsy in people with Klinefelter Syndrome, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly non-mosaic KS was considered as a model of a complete male infertility although few KS (4-8%) have an oligospermia. Read more about this study
- Who is it for?
- Ages 15 to 55 years, men only
- Conditions the study is for
- Klinefelter Syndrome
- What is being tested?
- Seminal analyses and testicular biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Sep 2010to 17 Sep 2018
- Phase
- Interventional
- 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 15 to 55 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Klinefelter Syndrome with 47,XXY non-mosaic
- Androgenotherapy stopped since more than 6 months
Who cannot join
- Antecedent of Radiotherapy or chemotherapy
- Psychological trouble
- Treatment interfering with spermatogenesis
- Androgenotherapy non stopped
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de Biologie de la Reproduction - CECOS - Groupe Hospitalier Pellegrin
Bordeaux, 33076
Service d'Endocrinologie Moléculaire et Maladies Rares, Centre de Biologie Est, Hospices Civils de Lyon
Bron, 69677
Service de Biologie de la Reproduction - Hôpital de la Conception
Marseille, 13385
Groupe de Médecine de la Reproduction - CECOS Midi-Pyrénées - Hôpital Paule de Viguier)
Toulouse, 31059
About this study
Official title: Fertility Preservation in Cases of Spermatogenesis Failure : Prospective Study for Klinefelter Syndrome With Non-mosaic Karyotype (47, XXY, Homogeneous)
Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly non-mosaic KS was considered as a model of a complete male infertility although few KS (4-8%) have an oligospermia. Recent studies in adult with non-mosaic KS reported the possibility of sperm retrieval by testicular biopsy (TESE) in around 50% cases and more than some pregnancies have been obtained after TESE with Intracytoplasmic Sperm Injection (ICSI). Since 1997, more than one hundred births are described.
As some studies shown a decrease of successful sperm retrieval with the increasing of age, we plan to compare the potential of sperm retrieval between two groups "adult" (23-55 years) and "young" after the onset of puberty (15-22 years). The study will be performed by searching spermatozoa on two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.
- Conditions
- Klinefelter Syndrome
- Being tested
- Seminal analyses and testicular biopsy
- Keywords
- Klinefelter Syndrome, Azoospermia, Seminal analyses, Testicular biopsy
- Medical subject headings
- Klinefelter Syndrome, Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seminal analyses and testicular biopsyProcedure or surgery
Two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.
| Study group | Role | What they receive |
|---|---|---|
| Young group | Experimental | Patient aged 15-22 years for seminal analyses and testicular biopsy Receives: Procedure: Seminal analyses and testicular biopsy |
| Adult group | Other | Patient aged 23-55 years for seminal analyses and testicular biopsy Receives: Procedure: Seminal analyses and testicular biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEsticular Sperm Extraction (TESE)
Improvement of sperm retrieval rate by Testicular Sperm extraction (TESE) in the "Young" group compare to "Adult" group.
Measured: 15 months
Secondary outcomes (3)
Androgenotherapy
Influence of antecedent of androgenotherapy before Testicular Sperm extraction (TESE) : treatment or not, duration of treatment
Measured: 15 months
Prognosis factors
Identification of prognosis factors of sperm retrieval (by TESE) in the two groups "Young" and "Adult"
Measured: 15 months
Histopathologist analyses
Histopathologist analyses of testicular biopsy in the two groups "Young" and "Adult". In the 2 groups, comparison of cases with and without sperm.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study start20 Sep 2010
- Primary completion17 Sep 2018
- Study completion17 Sep 2018
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 Klinefelter SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingrid PLOTTON, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918280
- Sponsor's protocol ID
- 2009.576
- Acronym
- FERTIPRESERVE
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2013
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Plotton I, Giscard d'Estaing S, Cuzin B, Brosse A, Benchaib M, Lornage J, Ecochard R, Dijoud F, Lejeune H; FERTIPRESERVE group. Preliminary results of a prospective study of testicular sperm extraction in young versus adult patients with nonmosaic 47,XXY Klinefelter syndrome. J Clin Endocrinol Metab. 2015 Mar;100(3):961-7. doi: 10.1210/jc.2014-3083. Epub 2014 Nov 25.
PubMed 25423570Renault L, Labrune E, Giscard d'Estaing S, Cuzin B, Lapoirie M, Benchaib M, Lornage J, Soignon G, de Souza A, Dijoud F, Fraison E, Pral-Chatillon L, Bordes A, Sanlaville D, Schluth-Bolard C, Salle B, Ecochard R, Lejeune H, Plotton I. Delaying testicular sperm extraction in 47,XXY Klinefelter patients does not impair the sperm retrieval rate, and AMH levels are higher when TESE is positive. Hum Reprod. 2022 Oct 31;37(11):2518-2531. doi: 10.1093/humrep/deac203.
PubMed 36112034
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Preservation in Cases of Spermatogenesis Failure : Prospective Study for Klinefelter Syndrome With Non-mosaic Karyotype (47, XXY, Homogeneous)
- ClinicalTrials.gov ID
- NCT01918280
- Acronym / sponsor ID
- FERTIPRESERVE / 2009.576
- Conditions
- Klinefelter Syndrome
- Keywords
- Klinefelter Syndrome, Azoospermia, Seminal analyses, Testicular biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Sep 2010 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 7 Aug 2013 (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.
Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly non-mosaic KS was considered as a model of a complete male infertility although few KS (4-8%) have an oligospermia. Recent studies in adult with non-mosaic KS reported the possibility of sperm retrieval by testicular biopsy (TESE) in around 50% cases and more than some pregnancies have been obtained after TESE with Intracytoplasmic Sperm Injection (ICSI). Since 1997, more than one hundred births are described.
As some studies shown a decrease of successful sperm retrieval with the increasing of age, we plan to compare the potential of sperm retrieval between two groups "adult" (23-55 years) and "young" after the onset of puberty (15-22 years). The study will be performed by searching spermatozoa on two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young group | Experimental | Procedure: Seminal analyses and testicular biopsyPatient aged 15-22 years for seminal analyses and testicular biopsy |
| Adult group | Other | Procedure: Seminal analyses and testicular biopsyPatient aged 23-55 years for seminal analyses and testicular biopsy |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Klinefelter Syndrome with 47,XXY non-mosaic
- Androgenotherapy stopped since more than 6 months
Key exclusion criteria (4 listed)
- Antecedent of Radiotherapy or chemotherapy
- Psychological trouble
- Treatment interfering with spermatogenesis
- Androgenotherapy non stopped
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 |
|---|---|---|
| Seminal analyses and testicular biopsyTwo seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses. | Procedure or surgery | Adult group, Young group |
Primary outcome
TEsticular Sperm Extraction (TESE)
Time frame: 15 months
Improvement of sperm retrieval rate by Testicular Sperm extraction (TESE) in the "Young" group compare to "Adult" group.
3 secondary outcomes
Androgenotherapy
Time frame: 15 months
Prognosis factors
Time frame: 15 months
Histopathologist analyses
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 25423570Plotton I, Giscard d'Estaing S, Cuzin B, Brosse A, Benchaib M, Lornage J, Ecochard R, Dijoud F, Lejeune H; FERTIPRESERVE group. Preliminary results of a prospective study of testicular sperm extraction in young versus adult patients with nonmosaic 47,XXY Klinefelter syndrome. J Clin Endocrinol Metab. 2015 Mar;100(3):961-7. doi: 10.1210/jc.2014-3083. Epub 2014 Nov 25.
- Results publication: PubMed 36112034Renault L, Labrune E, Giscard d'Estaing S, Cuzin B, Lapoirie M, Benchaib M, Lornage J, Soignon G, de Souza A, Dijoud F, Fraison E, Pral-Chatillon L, Bordes A, Sanlaville D, Schluth-Bolard C, Salle B, Ecochard R, Lejeune H, Plotton I. Delaying testicular sperm extraction in 47,XXY Klinefelter patients does not impair the sperm retrieval rate, and AMH levels are higher when TESE is positive. Hum Reprod. 2022 Oct 31;37(11):2518-2531. doi: 10.1093/humrep/deac203.
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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.
Ingrid PLOTTON, MD principal investigator
Hospices Civils de Lyon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seminal analyses and testicular biopsy in people with Klinefelter Syndrome, run by Hospices Civils de Lyon at 4 sites in France.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEsticular Sperm Extraction (TESE) (time frame: 15 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 NCT01918280, 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 19 Dec 2025.