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

November 1, 2023 updated by: Jens Fedder, Odense University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Odense, Denmark, DK-5000
        • Recruiting
        • Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
        • Contact:
          • Jens Fedder, MD, PhD
      • Odense, Denmark, DK-5000
        • Recruiting
        • Centre of Andrology & Fertility Clinic, Odense University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

Couples referred for micro-TESE

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cleavage rate
Time Frame: six years
Measurement of % of cleavage among the warmed oocytes
six years
Pregnancy rate
Time Frame: six years
Measurement of serum-hCG and ultrasonography at gestation age week 7
six years
Fertilization rate
Time Frame: six years
Measurement of % of fertilization among the warmed oocytes
six years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: six years
Measurement of the % of transferred embryos implanting into the uterus
six years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

January 16, 2019

First Submitted That Met QC Criteria

January 16, 2019

First Posted (Actual)

January 18, 2019

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lab.Reprod.Biol. - Odense.03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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