Clinical trial NCT02166567: Effect of Sorting of Apoptotic Spermatozoa on the Outcome of Assisted Reproduction
Official title: The Effect of Sorting of Non-apoptotic and Apoptotic Spermatozoa Using Flow Cytometry on the Outcome of Intracytoplasmic Sperm Injection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Keywords: intracytoplasmic sperm injection
Male infertility
apoptosis
flow cytometry and sorting
DNA fragmentation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: Week 12 of gestation
Secondary outcomes:
measure: Number of diploidic fertilized oocytes.
timeFrame: one day after intracytoplasmic sperm injection
Other outcomes:
measure: Number of embryos growing to the blastocyst stage
timeFrame: 5 days after intracytoplasmic sperm injection
measure: Implantation rate, e.g. number of implanted embryos with heart activity per number of embryos transferred
timeFrame: week 12 of gestation
Locations:
city: Basel
country: Switzerland
facility: University of Basel
state: Basel BS
Study officials:
affiliation: Univeristy Hospital Basel
name: Christian De Geyter, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.