The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes

NCT ID: NCT03809026

Last Updated: 2023-11-02

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

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-01

Study Completion Date

2024-06-30

Brief Summary

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Couples referred for microdissection-TESE (m-TESE) due to Klinefelter's syndrome, maturation stop in the spermatogenesis, or failed retrieval of testicular spermatozoa by conventional techniques with needle or TruCut are included. The women are stimulated with FSH in IVF protocols and the aspirated oocytes vitrified with usual applied techniques. Fresh sperm retrieved by micro-TESE are used for fertilization of the warmed oocytes. when it is not possible to obtain testicular sperm, the couples are offered fertilization with warmed oocytes.

Fertilization, cleavage, implantation and pregnancy rates using sperm from the patients versus from sperm donors will be compared.

Detailed Description

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Conditions

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Azoospermia, Nonobstructive

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Couples where the men have Klinefelter's syndrome, maturation stop in the spermatogenesis or failed retrieval of testicular sperm by conventional techniques with needle or TruCut, and where testicular sperm could be obtained by micro-TESE.

No interventions assigned to this group

Control group

Couples as in the study group, but where testicular sperm could not be obtained by micro-TESE. The oocytes therefore must be fertilized using donor sperm.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Couples referred for micro-TESE

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jens Fedder

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Centre of Andrology & Fertility Clinic, Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Jens Fedder, MD, PhD

Role: CONTACT

+45 26820368

Facility Contacts

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Jens Fedder, MD, PhD

Role: primary

Jens Fedder, MD, PhD

Role: primary

+45 26820368

Other Identifiers

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Lab.Reprod.Biol. - Odense.03

Identifier Type: -

Identifier Source: org_study_id

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