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出境医 / 临床实验 / The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes

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

Study Description
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

Study Design
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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
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
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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

Contacts and Locations

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

Locations
Layout table for location information
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
Tracking Information
First Submitted Date January 16, 2019
First Posted Date January 18, 2019
Last Update Posted Date March 18, 2020
Actual Study Start Date September 1, 2015
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 16, 2019)
  • Cleavage rate [ Time Frame: six years ]
    Measurement of % of cleavage among the warmed oocytes
  • Pregnancy rate [ Time Frame: six years ]
    Measurement of serum-hCG and ultrasonography at gestation age week 7
  • Fertilization rate [ Time Frame: six years ]
    Measurement of % of fertilization among the warmed oocytes
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 16, 2019)
Implantation rate [ Time Frame: six years ]
Measurement of the % of transferred embryos implanting into the uterus
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes
Official Title The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Azoospermia, Nonobstructive
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 16, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Couples referred for micro-TESE

Exclusion Criteria:

None

Sex/Gender
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.
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Jens Fedder, MD, PhD +45 26820368 fedder@dadlnet.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT03809026
Other Study ID Numbers Lab.Reprod.Biol. - Odense.03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jens Fedder, Odense University Hospital
Study Sponsor Odense University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Odense University Hospital
Verification Date March 2020