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

NCT03809026 | Unknown

• 1 other identifier: Lab.Reprod.Biol. - Odense.03
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Azoospermia, Nonobstructive

Keywords

Azoospermia; micro-TESE; Klinefelter's syndrome; Cryptorchidism; Vitrified oocytes

Outcome Measures

Primary Outcomes (3)

• Cleavage rate

  Measurement of % of cleavage among the warmed oocytes

  six years

• Pregnancy rate

  Measurement of serum-hCG and ultrasonography at gestation age week 7

  six years

• Fertilization rate

  Measurement of % of fertilization among the warmed oocytes

  six years

Secondary Outcomes (1)

• Implantation rate

  six years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Actually we treat infertile couples with a man and a woman, but the variable originates from the man.
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Couples referred for micro-TESE

You may not qualify if:

• None

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (2)

Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital

Odense, DK-5000, Denmark

RECRUITING

Centre of Andrology & Fertility Clinic, Odense University Hospital

Odense, DK-5000, Denmark

RECRUITING

MeSH Terms

Conditions

Azoospermia, Nonobstructive; Azoospermia; Klinefelter Syndrome; Cryptorchidism

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Testicular Diseases

Central Study Contacts

Jens Fedder, MD, PhD

CONTACT

+45 26820368; fedder@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 18, 2019
• Study Start: September 1, 2015
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-11

Locations

DK (2)