Infertility Clinical Trial
Official title:
Validation of Addition of Uterine Fluid to Human Embryo Culture Medium
Infertility or infertility affects about 15% of couples of reproductive age. It is estimated
that 80 million people around the world suffer from this problem. Assisted reproduction
techniques (ART) use culture media (during in vitro fertilization or early embryo
development) with protein sources that are very different from natural sources. This media
could produce an added stress to the gametes and embryos that could cause epigenetic
alterations and health effects during adult life.
Our working hypothesis is based on studies in animal models (pig and cow), in which it was
observed that the culture media with reproductive fluids used as additives instead of
conventional sources of proteins (such as serum albumin) , produce embryos with an epigenetic
profile closer to that of embryos generated in the maternal oviduct. Moreover, with these
fluids, blastocysts obtained have a greater number of cells and hatchability than those
produced with serum albumin alone.
Therefore, the University of Murcia, with an extensive experience in this area, and the IVI
Murcia (Valencian Infertility Institute) research team have come together to launch this
research project in order to determine the advantages of the use of human reproductive fluids
as additives in embryonic culture media. To do this, 2 specific objectives are proposed,:
1. Creation of the first collection of human uterine fluid samples for Assisted
Reproduction use.
2. To evaluate the use of uterine fluid as a media supplement in the culture media for
assisted reproduction techniques, by evaluating embryo quality cultured with autologous
fluid from voluntary patients (autologous culture)
This achievement would allow us the development of protocols in the nearest ART physiological
conditions which represent not only a technical challenge but a biomedical responsibility
that must be addressed to prevent future diseases of the offspring.
1. Creation of the first collection of human uterine fluid samples for Assisted
Reproduction use. Female reproductive system will be collected at the Virgen de la
Arrixaca University Clinical Hospital from surgical pieces of patients undergoing
surgical procedures. IVI Murcia Clinics uterine fluids from oocyte donors will be
collected. These fluids will be store in the Arrixaca Hospital Biobank for future
researches.
2. Validation of the addition of uterine fluid to human embryonic culture media:
Couples undergoing assited Reproduction Treatment in IVI Murcia will be asked for their
inclusion in this study. Uterine fluid will be take 48 hours after peak of LH (luteinizing
hormone), in natural cycle. Oocytes from these patients, will be divided into two groups:
Half of the zygotes of each patient, control group, will be grown in the conditions usually
used in the clinic, and the other half, experimental group, will add 1-5% of uterine fluid
from the patient (v / v)
On day 3 and on day 5 of culture the quality of the embryos in both groups will be assessed
according to the usual criteria of the clinic and the best quality and highest probability of
implantation will be transferred, following the usual clinical practice. The samples of
uterine fluid, after the initial processing in the IVI-Murcia clinic will be transferred to
the Department of Physiology of the University of Murcia where they will be fractionated to
perform a quality control according to the following specifications:
Uterine fluid pH 7.0-7.6 Osmolarity (mOsm / kg) 260-320 Endotoxin (EU / mL) <0.15 Sterility
No growth
Only samples that meet these criteria will continue to be part of the study
;
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