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

Not Applicable

Completed

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

• Registration Number: NCT02166567
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-06-14
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-18
• Primary Completion: 2017-01
• Study Completion: 2017-11
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YoPro and FACS	Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with 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.
Swim-up	Swim-up	Spermatozoa will be processed using the conventional swim-up me

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	Week 12 of gestation

Secondary Outcome Measures

Name	Time	Method
Number of diploidic fertilized oocytes.	one day after intracytoplasmic sperm injection

Trial Locations

Locations (1)

University of Basel; 🇨🇭 Basel, Basel BS, Switzerland