A novel, simple method to obtain monofollicular punctates and the corresponding oocytes during oocyte pick ups for IVF or IVF/ICSI

In routine IVF treatments, pre-ovulatory follicles are punctuated under
different circumstances. In the early days of IVF, the laparoscopic (Steptoe
and Edwards 1970) and the transvescical (Robertson, Picker et al. 1986) method
was used, while today all oocyte retrievals are being done vaginally (Kemeter
and Feichtinger 1986). Some clinics routinely flush the follicles (Bagtharia
and Haloob 2005) and others don*t. In most cases the obtained punctate will be
pooled, ie fluid and the oocytes from different follicles will be collected in
one larger bottle or tube, as the follicles will be punctuated one after
another without withdrawing the needle again and again. This method is
obviously simple and fast. However, today, an increasing interest exists in
different parameters regarding the micro environment of the oocyte in relation
to oocyte and embryo quality, implantation and pregnancy outcome (Boxmeer,
Brouns et al. 2008), (Rosen, Shen et al. 2007). Therefore, some authors have
published data after retrieving mono-follicular punctuates (Boxmeer, Brouns et
al. 2008).
Different methods exist to obtain a mono-follicular punctate. A single
follicle can be punctured and the fluid from this single follicle can be
collected in a separate bottle or tube. The bottle will be replaced (without
withdrawing the needle from the ovary) and the next follicle will be punctured.
The disadvantage of this method is that a relatively large amount of the
follicular fluid of the first follicle will not be collected in the separate
first sample but will stay behind in the tubing and the needle of the
collecting system. This fluid will be collected during puncturing the next
follicle. Therefore concentrations of different contents of the fluid of a
single follicle can only be assessed from the first sample, as the consecutive
samples will be mixed. Moreover, as a relatively large amount of fluid remains
in the tubing and needle, the chance that the corresponding oocyte is present
in the separate first sample is relatively low. To overcome these problems it
is also possible to withdraw the needle from the ovary and change bottles after
puncturing every single follicle. This will obviously increase duration of the
procedure, increase pain and discomfort for the patients and probably cause
more tissue damage in the ovaries (El-Shawarby, Margara et al. 2004).
In order to be able to collect mono follicular samples together with the
corresponding oocyte effectively a new oocyte pick up needle was designed and
manufactured (Gynotec, Malden, The Netherlands). The aim of this study examine
the effectivity and safety of the use of this new needle.

The objective of this study is to prove that the number of oocytes and the
quality of embryos obtained from these oocytes harvested with this new needle
is comparable with the number of oocytes and quality of embryos obtained from
oocytes harvested with a conventional needle.

All couples who will be starting an IVF or ICSI treatment in the ErasmusMC are
being invited for an information evening (in which the entire treatment as well
as the laboratory procedures will be explained). Within weeks after this
evening an intake with these couples willl take place. Thereafter the iVF
treatment will actually start.
During the information evening, the researcher will present a couple of slides
regarding the study. Moreover, couples will receive the patient information
form. During intake, the fertilitity doctor will ask the couple to participate.
Couples can get additional information if needed at that moment. This is the
moment to sign the informed consent.
If on the day of ovum pick up a patient turns out to be elegible, and if she
has signed the informed consent, randomisation can take place. The
randomisation dictates which ovary will be punctured monofillicular and which
pooled. The right ovary will allways be punctured first. All ovum pick ups will
be performed by the same doctor (the researcher)

As the efficacy of this needle will be tested during a procudere which patients
will undergo during their IVF treatment, they do not undergo an extra
intervention. Therefore, both burden and risk are comparable for participants
and non participants. The duration of the oocyte pick pick up could possibly be
slightly increased due to the increased changing of the bottles.
Theorettically, the new needle could give a lower yield in oocytes. However, as
in one procedure both the conventional and the new needle will be used, the
risk of reduced pregnancy chances can be considered as low.