Choice Preclinical Gametes Study - Sperm Survival

The Choice device is intended to prevent pregnancy when closed, but also to
facilitate pregnancy when opened. To facilitate pregnancy, the sperm cells
should be able to move through the Choice device to reach the ovum in the
ampulla of the fallopian tube. This can only be achieved when the sperm cells
survive in the presence of the Choice device and the materials it is made of.

The purpose of this preclinical study is to obtain a quantitative measurement
about the survival of human sperm cells when in contact with the Choice device.
This in order to study safety and biocompatibility of the materials used for
the Choice device and to enhance the further development of Choice. When the
materials used for the Choice device enable sperm to survive just as good as
they normally would (without a Choice device present), this provides additional
information about biocompatibility of the materials used.

In order to test the human sperm survival rates a routine semen analysis will
be performed with focus on viability.
- Sperm count (number and percentage of survival)
- Motility (survival)
- Volume
- PH (optional)

In total 5 healthy male volunteers in the age 18-50 are requested to donate
sperm. These men will be asked to refrain from having sex or masturbation for
2-5 days before sample collection. Semen of those volunteers will be processed
according the UMCU standard viability testing protocol (see below) with the
addition of the Choice device in the Petri dish.
The sperm sample of the five volunteers will be divided into two petri dishes,
which means they will be their own control group:
- Group A - semen sample without Choice Device (N = 5)
- Group B - semen sample with a (sterile) Choice Device (N=5)

In the event that one or more of the voluntary donors has a semen motility rate
of less than 30 percent and/or zero spermatozoa this donor material must be
replaced. Therewith the total number of voluntary donors could possibly exceed
5 so that in total 10 petri dishes with semen samples will be processed and
counted (number of sperm cells per ml) in a so called Makler or Neubauer
countingroom. After 24 hours an evaluation will be made of the number surviving
(%) sperm cells in the same countingroom. Those 2 values: sperm cell count per
ml and survival (%) before and after 24 hours will be the measurement of this
study.

It is very important that the Choice Device that will be placed in the petri
dishes is sterile as contamination has major impact on survival.

None.