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

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ClinicalTrials.gov Identifier: NCT03809026
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Jens Fedder, Odense University Hospital

Brief Summary:

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.


Condition or disease
Azoospermia, Nonobstructive

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Group/Cohort
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.
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.



Primary Outcome Measures :
  1. Cleavage rate [ Time Frame: six years ]
    Measurement of % of cleavage among the warmed oocytes

  2. Pregnancy rate [ Time Frame: six years ]
    Measurement of serum-hCG and ultrasonography at gestation age week 7

  3. Fertilization rate [ Time Frame: six years ]
    Measurement of % of fertilization among the warmed oocytes


Secondary Outcome Measures :
  1. Implantation rate [ Time Frame: six years ]
    Measurement of the % of transferred embryos implanting into the uterus



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Actually we treat infertile couples with a man and a woman, but the variable originates from the man.
Sampling Method:   Non-Probability Sample
Study Population
Men referred to micro-TESE due to Klinefelter's syndrome, maturation stop in the spermatogenesis, or failed sperm retrieval using conventional needles or TruCut.
Criteria

Inclusion Criteria:

Couples referred for micro-TESE

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809026


Contacts
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Contact: Jens Fedder, MD, PhD +45 26820368 fedder@dadlnet.dk

Locations
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Denmark
Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital Recruiting
Odense, Denmark, DK-5000
Contact: Jens Fedder, MD, PhD         
Centre of Andrology & Fertility Clinic, Odense University Hospital Recruiting
Odense, Denmark, DK-5000
Contact: Jens Fedder, MD, PhD    +45 26820368    fedder@dadlnet.dk   
Sponsors and Collaborators
Odense University Hospital

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Responsible Party: Jens Fedder, Professor, MD, PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03809026     History of Changes
Other Study ID Numbers: Lab.Reprod.Biol. - Odense.03
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jens Fedder, Odense University Hospital:
Azoospermia
micro-TESE
Klinefelter's syndrome
Cryptorchidism
Vitrified oocytes

Additional relevant MeSH terms:
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Azoospermia
Infertility, Male
Infertility
Genital Diseases, Male