CClinicalTrials.gg
RecruitingNCT03809026Updated Nov 2, 2023

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

An observational study in Azoospermia, Nonobstructive, sponsored by Odense University Hospital. Recruiting at 2 sites in Denmark. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by Odense University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 100 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Azoospermia, Nonobstructive

Browse trials for

Keywords

  • Azoospermia
  • micro-TESE
  • Klinefelter's syndrome
  • Cryptorchidism
  • Vitrified oocytes
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Male
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.

Inclusion criteria

Couples referred for micro-TESE

Exclusion criteria

Exclusion Criteria:

None

04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and 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.

05

What researchers measure

Primary outcomes

  1. Cleavage rate

    Measurement of % of cleavage among the warmed oocytes

    Time frame: six years

  2. Pregnancy rate

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

    Time frame: six years

  3. Fertilization rate

    Measurement of % of fertilization among the warmed oocytes

    Time frame: six years

Secondary outcomes

  1. Implantation rate

    Measurement of the % of transferred embryos implanting into the uterus

    Time frame: six years

06

Study locations

2 of 2 sites recruiting
  • Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
    Odense, DK-5000, Denmark
    • Jens Fedder, MD, PhD · Contact
    Recruiting
  • Centre of Andrology & Fertility Clinic, Odense University Hospital
    Odense, DK-5000, Denmark
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03809026
Lead sponsor
Odense University Hospital
Responsible party
Jens Fedder (Professor, MD, PhD, Odense University Hospital) — Principal investigator
First posted
Jan 18, 2019
Start date
Sep 1, 2015
Primary completion
Dec 31, 2023 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Nov 2, 2023

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion