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

Azoospermia, Nonobstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03809026
• Other study ID #: Lab.Reprod.Biol. - Odense.03
• Status: Recruiting
• Start date: September 1, 2015
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Odense University Hospital
• Contact: Jens Fedder, MD, PhD
• Phone: +45 26820368
• Email: fedder[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Couples referred for micro-TESE

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Azoospermia
• Azoospermia, Nonobstructive

Locations

Country	Name	City	State
Denmark	Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital	Odense
Denmark	Centre of Andrology & Fertility Clinic, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cleavage rate	Measurement of % of cleavage among the warmed oocytes	six years
Primary	Pregnancy rate	Measurement of serum-hCG and ultrasonography at gestation age week 7	six years
Primary	Fertilization rate	Measurement of % of fertilization among the warmed oocytes	six years
Secondary	Implantation rate	Measurement of the % of transferred embryos implanting into the uterus	six years