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Fertility Preservation in Cases of Klinefelter Syndrome.

NCT ID: NCT01918280

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-20

Study Completion Date

2018-09-17

Brief Summary

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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.

Detailed Description

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Conditions

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Klinefelter Syndrome

Keywords

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Klinefelter Syndrome Azoospermia Seminal analyses Testicular biopsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Young group

Patient aged 15-22 years for seminal analyses and testicular biopsy

Group Type EXPERIMENTAL

Seminal analyses and testicular biopsy

Intervention Type PROCEDURE

Two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.

Adult group

Patient aged 23-55 years for seminal analyses and testicular biopsy

Group Type OTHER

Seminal analyses and testicular biopsy

Intervention Type PROCEDURE

Two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.

Interventions

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Seminal analyses and testicular biopsy

Two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Klinefelter Syndrome with 47,XXY non-mosaic
* Androgenotherapy stopped since more than 6 months

Exclusion Criteria

* Antecedent of Radiotherapy or chemotherapy
* Psychological trouble
* Treatment interfering with spermatogenesis
* Androgenotherapy non stopped
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ingrid PLOTTON, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Service de Biologie de la Reproduction - CECOS - Groupe Hospitalier Pellegrin

Bordeaux, , France

Site Status

Service d'Endocrinologie Moléculaire et Maladies Rares, Centre de Biologie Est, Hospices Civils de Lyon

Bron, , France

Site Status

Service de Biologie de la Reproduction - Hôpital de la Conception

Marseille, , France

Site Status

Groupe de Médecine de la Reproduction - CECOS Midi-Pyrénées - Hôpital Paule de Viguier)

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 25423570 (View on PubMed)

Renault 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.

Reference Type RESULT
PMID: 36112034 (View on PubMed)

Other Identifiers

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2009.576

Identifier Type: -

Identifier Source: org_study_id