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

December 11, 2017 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Switzerland
    • Basel BS
      • Basel, Basel BS, Switzerland, CH-4031
        • University of Basel

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

22 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: YoPro and FACS
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.
Procedure: Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS
Other Names:
  • FACS
  • YoPro
ACTIVE_COMPARATOR: Swim-up
Spermatozoa will be processed using the conventional swim-up me
Procedure: Swim-up
Semen processing will be carried out with the conventional swim-up method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy rate
Time Frame: Week 12 of gestation
Week 12 of gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of diploidic fertilized oocytes.
Time Frame: one day after intracytoplasmic sperm injection
one day after intracytoplasmic sperm injection

Other Outcome Measures

Outcome Measure
Time Frame
Number of embryos growing to the blastocyst stage
Time Frame: 5 days after intracytoplasmic sperm injection
5 days after intracytoplasmic sperm injection
Implantation rate, e.g. number of implanted embryos with heart activity per number of embryos transferred
Time Frame: week 12 of gestation
week 12 of gestation

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Christian De Geyter, MD, Prof., Univeristy Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2013

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

June 14, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (ESTIMATE)

June 18, 2014

Study Record Updates

Last Update Posted (ACTUAL)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKBB178/12
  • YOPRO (OTHER: University of Basel)

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.

Subscribe