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 |
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Azoospermia, Nonobstructive |
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 |
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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.
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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.
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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 |
Inclusion Criteria:
Couples referred for micro-TESE
Exclusion Criteria:
None
Contact: Jens Fedder, MD, PhD | +45 26820368 | fedder@dadlnet.dk |
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 |
Tracking Information | |||||||
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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 |
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
Implantation rate [ Time Frame: six years ] Measurement of the % of transferred embryos implanting into the uterus
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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. |
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Detailed Description | Not Provided | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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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 |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Recruiting | ||||||
Estimated Enrollment |
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 |
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Sex/Gender |
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Ages | 18 Years to 100 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | Not Provided | ||||||
Contacts |
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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 |
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IPD Sharing Statement |
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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 |