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

NCT02166567 | Completed DMC

• 2 other identifiers: EKBB178/12YOPRO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility

Keywords

intracytoplasmic sperm injection; Male infertility; apoptosis; flow cytometry and sorting; DNA fragmentation

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  Week 12 of gestation

Secondary Outcomes (1)

• Number of diploidic fertilized oocytes.

  one day after intracytoplasmic sperm injection

Other Outcomes (2)

• 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

Study Arms (2)

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.

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

Procedure: Swim-up

Interventions

Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS PROCEDURE

Also known as: YoPro, FACS

YoPro and FACS

Swim-up PROCEDURE

Semen processing will be carried out with the conventional swim-up method.

Swim-up

Eligibility Criteria

• Age: 22 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University of Basel

Basel, Basel BS, CH-4031, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 23809499 BACKGROUND

• 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.

  PMID: 31463874 DERIVED

MeSH Terms

Conditions

Infertility, Male

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Christian De Geyter, MD, Prof.

  Univeristy Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2014
• First Posted: June 18, 2014
• Study Start: May 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

CH (1)