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Completed

NCT Number: NCT02166567

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

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.

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Key information

Conditions

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

Age range

22 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel

Basel, Basel BS, CH-4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

Other names: YoPro, FACS

Swim-up

Procedure

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

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: Week 12 of gestation

Secondary outcomes

  1. Number of diploidic fertilized oocytes.

    Time frame: one day after intracytoplasmic sperm injection

Other outcomes

  1. Number of embryos growing to the blastocyst stage

    Time frame: 5 days after intracytoplasmic sperm injection

  2. Implantation rate, e.g. number of implanted embryos with heart activity per number of embryos transferred

    Time frame: week 12 of gestation

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

The Effect of Sorting of Non-apoptotic and Apoptotic Spermatozoa Using Flow Cytometry on the Outcome of Intracytoplasmic Sperm Injection.

Acronym: Spermsorting

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 18, 2014
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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