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

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: Male Infertility
• Intervention / Treatment: Procedure: Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS; Procedure: Swim-up

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Week 12 of gestation

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Christian De Geyter, MD, Prof., Univeristy Hospital Basel

Publications and helpful links

General 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.
• 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.

Study record dates

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: apoptosis; Male infertility; intracytoplasmic sperm injection; DNA fragmentation; flow cytometry and sorting
• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• 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