Male InfertilitySpermsortingNCT02166567
Effect of Sorting of Apoptotic Spermatozoa on the Outcome of Assisted Reproduction
A study testing Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS and Swim-up in people with Male Infertility, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods rely on physical properties of the spermatozoa, such as the swim-up methods and density gradient centrifugation. Read more about this study
- Who is it for?
- Ages 22 to 39 years
- Conditions the study is for
- Male Infertility
- What is being tested?
- Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS and Swim-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Nov 2017
- Phase
- Interventional
- 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 22 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- infertile couples needing treatment with ICSI
- male infertility as defined by the WHO 2010 criteria
- age of the treated women should be between 22 and 39 years of age.
- normal ovarian reserve, as defined by basal FSH-concentration below 10 IU/l and AMH-concentration above 10 pmol/l.
- signed consent form.
Who cannot join
- normal male infertility, as defined by the WHO 2010 criteria
- age of the treated women below 22 years and above 39 years
- reduced ovarian reserve, as defined by an elevated basal FSH-concentration or reduced AMH-concentration.
- Not more than two preceding unsuccessfull treatments with ICSI
- Severe disease of the male or female partner, such as HIV, hepatitis, or psychiatric illness.
- Participation in another study.
- lack of a signed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sorting of Non-apoptotic and Apoptotic Spermatozoa Using Flow Cytometry on the Outcome of Intracytoplasmic Sperm Injection.
In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods rely on physical properties of the spermatozoa, such as the swim-up methods and density gradient centrifugation. It is now known that current processing of spermatozoa does not prevent the admixture of spermatozoa with damaged genetic material. The latter have a negative impact on the outcome of ART. The investigators developed a new method for the processing of spermatozoa with intact genetic material based on flow cytometry and sorting (FACS) and on staining using a deye, YoPro. The investigators aim at examining the effect of this novel method of sperm sorting on the outcome of ART.
- Conditions
- Male Infertility
- Being tested
- Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS, Swim-up
- Keywords
- intracytoplasmic sperm injection, Male infertility, apoptosis, flow cytometry and sorting, DNA fragmentation
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACSProcedure or surgery
Also called YoPro, FACS
Swim-upProcedure or surgery
Semen processing will be carried out with the conventional swim-up method.
| Study group | Role | What they receive |
|---|---|---|
| YoPro and FACS | Experimental | Spermatozoa to be used for ICSI will be stained with the YoPro Dye and then be sorted with FACS to select non-YoPro stained spermatozoa, known to have significantly less fragmented DNA. Receives: Procedure: Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS |
| Swim-up | Active comparator | Spermatozoa will be processed using the conventional swim-up me Receives: Procedure: Swim-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Measured: Week 12 of gestation
Secondary outcomes (1)
Number of diploidic fertilized oocytes.
Measured: one day after intracytoplasmic sperm injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startMay 2013
- Primary completionJan 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian De Geyter, MD, Prof., Principal investigator, Univeristy Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166567
- Sponsor's protocol ID
- EKBB178/12
- Other IDs
- YOPRO
- Acronym
- Spermsorting
- Status last verified
- Dec 2017
- First submitted
- 14 Jun 2014
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ribeiro SC, Sartorius G, Pletscher F, de Geyter M, Zhang H, de Geyter C. Isolation of spermatozoa with low levels of fragmented DNA with the use of flow cytometry and sorting. Fertil Steril. 2013 Sep;100(3):686-94. doi: 10.1016/j.fertnstert.2013.05.030. Epub 2013 Jun 27.
PubMed 23809499De Geyter C, Gobrecht-Keller U, Ahler A, Fischer M. Removal of DNA-fragmented spermatozoa using flow cytometry and sorting does not improve the outcome of intracytoplasmic sperm injection. J Assist Reprod Genet. 2019 Oct;36(10):2079-2086. doi: 10.1007/s10815-019-01571-1. Epub 2019 Aug 28.
PubMed 31463874
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sorting of Non-apoptotic and Apoptotic Spermatozoa Using Flow Cytometry on the Outcome of Intracytoplasmic Sperm Injection.
- ClinicalTrials.gov ID
- NCT02166567
- Acronym / sponsor ID
- Spermsorting / EKBB178/12
- Conditions
- Male Infertility
- Keywords
- intracytoplasmic sperm injection, Male infertility, apoptosis, flow cytometry and sorting, DNA fragmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 18 Jun 2014 (estimated)
- 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.
In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods rely on physical properties of the spermatozoa, such as the swim-up methods and density gradient centrifugation. It is now known that current processing of spermatozoa does not prevent the admixture of spermatozoa with damaged genetic material. The latter have a negative impact on the outcome of ART. The investigators developed a new method for the processing of spermatozoa with intact genetic material based on flow cytometry and sorting (FACS) and on staining using a deye, YoPro. The investigators aim at examining the effect of this novel method of sperm sorting on the outcome of ART.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YoPro and FACS | Experimental | Procedure: Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACSSpermatozoa to be used for ICSI will be stained with the YoPro Dye and then be sorted with FACS to select non-YoPro stained spermatozoa, known to have significantly less fragmented DNA. |
| Swim-up | Active comparator | Procedure: Swim-upSpermatozoa will be processed using the conventional swim-up me |
Who may qualify
- Ages
- 22 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- infertile couples needing treatment with ICSI
- male infertility as defined by the WHO 2010 criteria
- age of the treated women should be between 22 and 39 years of age.
- normal ovarian reserve, as defined by basal FSH-concentration below 10 IU/l and AMH-concentration above 10 pmol/l.
- signed consent form.
Key exclusion criteria (7 listed)
- normal male infertility, as defined by the WHO 2010 criteria
- age of the treated women below 22 years and above 39 years
- reduced ovarian reserve, as defined by an elevated basal FSH-concentration or reduced AMH-concentration.
- Not more than two preceding unsuccessfull treatments with ICSI
- Severe disease of the male or female partner, such as HIV, hepatitis, or psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACSAlso: YoPro, FACS | Procedure or surgery | YoPro and FACS |
| Swim-upSemen processing will be carried out with the conventional swim-up method. | Procedure or surgery | Swim-up |
Primary outcome
Ongoing pregnancy rate
Time frame: Week 12 of gestation
1 secondary outcome
Number of diploidic fertilized oocytes.
Time frame: one day after intracytoplasmic sperm injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Background: PubMed 23809499Ribeiro SC, Sartorius G, Pletscher F, de Geyter M, Zhang H, de Geyter C. Isolation of spermatozoa with low levels of fragmented DNA with the use of flow cytometry and sorting. Fertil Steril. 2013 Sep;100(3):686-94. doi: 10.1016/j.fertnstert.2013.05.030. Epub 2013 Jun 27.
- Derived from this study: PubMed 31463874De Geyter C, Gobrecht-Keller U, Ahler A, Fischer M. Removal of DNA-fragmented spermatozoa using flow cytometry and sorting does not improve the outcome of intracytoplasmic sperm injection. J Assist Reprod Genet. 2019 Oct;36(10):2079-2086. doi: 10.1007/s10815-019-01571-1. Epub 2019 Aug 28.
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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.
Christian De Geyter, MD, Prof. principal investigator
Univeristy Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS and Swim-up in people with Male Infertility, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: Week 12 of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166567, which also lists 2 linked publications.
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 12 Dec 2017.