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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Male Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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YoPro and 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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Swim-up

Spermatozoa will be processed using the conventional swim-up me

Group Type ACTIVE_COMPARATOR

Swim-up

Intervention Type PROCEDURE

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

Interventions

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

Intervention Type PROCEDURE

Swim-up

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

Intervention Type PROCEDURE

Other Intervention Names

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YoPro FACS

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No