search
Back to results

Effect of Sorting of Apoptotic Spermatozoa on the Outcome of Assisted Reproduction (Spermsorting)

Primary Purpose

Male Infertility

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS
Swim-up
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Infertility focused on measuring intracytoplasmic sperm injection, Male infertility, apoptosis, flow cytometry and sorting, DNA fragmentation

Eligibility Criteria

22 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

YoPro and FACS

Swim-up

Arm Description

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.

Spermatozoa will be processed using the conventional swim-up me

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate

Secondary Outcome Measures

Number of diploidic fertilized oocytes.

Full Information

First Posted
June 14, 2014
Last Updated
December 11, 2017
Sponsor
University Hospital, Basel, Switzerland
search

1. Study Identification

Unique Protocol Identification Number
NCT02166567
Brief Title
Effect of Sorting of Apoptotic Spermatozoa on the Outcome of Assisted Reproduction
Acronym
Spermsorting
Official Title
The Effect of Sorting of Non-apoptotic and Apoptotic Spermatozoa Using Flow Cytometry on the Outcome of Intracytoplasmic Sperm Injection.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
intracytoplasmic sperm injection, Male infertility, apoptosis, flow cytometry and sorting, DNA fragmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YoPro and FACS
Arm Type
Experimental
Arm Description
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.
Arm Title
Swim-up
Arm Type
Active Comparator
Arm Description
Spermatozoa will be processed using the conventional swim-up me
Intervention Type
Procedure
Intervention Name(s)
Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS
Other Intervention Name(s)
YoPro, FACS
Intervention Type
Procedure
Intervention Name(s)
Swim-up
Intervention Description
Semen processing will be carried out with the conventional swim-up method.
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Time Frame
Week 12 of gestation
Secondary Outcome Measure Information:
Title
Number of diploidic fertilized oocytes.
Time Frame
one day after intracytoplasmic sperm injection
Other Pre-specified Outcome Measures:
Title
Number of embryos growing to the blastocyst stage
Time Frame
5 days after intracytoplasmic sperm injection
Title
Implantation rate, e.g. number of implanted embryos with heart activity per number of embryos transferred
Time Frame
week 12 of gestation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian De Geyter, MD, Prof.
Organizational Affiliation
Univeristy Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Basel
City
Basel
State/Province
Basel BS
ZIP/Postal Code
CH-4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23809499
Citation
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.
Results Reference
background
PubMed Identifier
31463874
Citation
De 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.
Results Reference
derived

Learn more about this trial

Effect of Sorting of Apoptotic Spermatozoa on the Outcome of Assisted Reproduction

We'll reach out to this number within 24 hrs