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 : March 18, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
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.
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.
- 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
- Implantation rate [ Time Frame: six years ]Measurement of the % of transferred embryos implanting into the uterus
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
|Contact: Jens Fedder, MD, PhD||+45 email@example.com|
|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 firstname.lastname@example.org|