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

Male Infertility Clinical Trial

— Spermsorting  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166567
• Other study ID #: EKBB178/12
• Secondary ID: YOPRO
• Status: Completed
• Phase: N/A
• First received: June 14, 2014
• Last updated: December 11, 2017
• Start date: May 2013
• Est. completion date: November 2017

Study information

• Verified date: December 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Procedure:
• Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS

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

Locations

Country	Name	City	State
Switzerland	University of Basel	Basel	Basel BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of embryos growing to the blastocyst stage		5 days after intracytoplasmic sperm injection
Other	Implantation rate, e.g. number of implanted embryos with heart activity per number of embryos transferred		week 12 of gestation
Primary	Ongoing pregnancy rate		Week 12 of gestation
Secondary	Number of diploidic fertilized oocytes.		one day after intracytoplasmic sperm injection