Azoospermia, NonobstructiveNCT03809026
The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes
An observational study of Azoospermia, Nonobstructive, run by Odense University Hospital at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Azoospermia, Nonobstructive
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Sep 2015to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- Adult, Older adult
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.
Who may be able to join
- Couples referred for micro-TESE
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
Odense, DK-5000
Jens Fedder, MD, PhD
- Recruiting
Centre of Andrology & Fertility Clinic, Odense University Hospital
Odense, DK-5000
Jens Fedder, MD, PhD, +45 26820368, fedder@dadlnet.dk
About this study
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
- Medical subject headings
- Azoospermia, Nonobstructive, Azoospermia, Klinefelter Syndrome, Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Cleavage rate
Measurement of % of cleavage among the warmed oocytes
Measured: six years
Pregnancy rate
Measurement of serum-hCG and ultrasonography at gestation age week 7
Measured: six years
Fertilization rate
Measurement of % of fertilization among the warmed oocytes
Measured: six years
Secondary outcomes (1)
Implantation rate
Measurement of the % of transferred embryos implanting into the uterus
Measured: six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Sep 2015
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Azoospermia, NonobstructiveStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Fedder, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809026
- Sponsor's protocol ID
- Lab.Reprod.Biol. - Odense.03
- Status last verified
- Nov 2023
- First submitted
- 16 Jan 2019
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes
- ClinicalTrials.gov ID
- NCT03809026
- Acronym / sponsor ID
- Lab.Reprod.Biol. - Odense.03
- Conditions
- Azoospermia, Nonobstructive
- Keywords
- Azoospermia, micro-TESE, Klinefelter's syndrome, Cryptorchidism, Vitrified oocytes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Couples referred for micro-TESE
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Implantation rate
Time frame: six years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Azoospermia, Nonobstructive
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
RecruitingObservational study
Maternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men
Azoospermia, Nonobstructive, Cryptozoospermia
Enrolling by invitationPhase 2
Isotretinoin vs hCG for Male Infertility Due to Low or Absent Sperm
Oligospermia, Azoospermia, Nonobstructive
RecruitingObservational study
Identifying Genome Variants in Non-Obstructive Azoospermia (NOA) or Primary Ovarian Insufficiency (POI)
Primary Ovarian Insufficiency, Azoospermia
Active, not recruiting
Autologous Transplantation of Human Cryopreserved Testis Tissue
Cancer, Hematologic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Azoospermia, Nonobstructive, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Fedder, MD, PhD (+45 26820368, fedder@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cleavage rate (time frame: six years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.