Validation of Addition of Uterine Fluid to Human Embryo Culture Medium
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|ClinicalTrials.gov Identifier: NCT03436758|
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
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,:
- Creation of the first collection of human uterine fluid samples for Assisted Reproduction use.
- 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.
|Condition or disease|
- 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.
- 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
|Study Type :||Observational|
|Estimated Enrollment :||27 participants|
|Official Title:||Validation of Addition of Uterine Fluid to Human Embryo Culture Medium|
|Actual Study Start Date :||January 30, 2018|
|Estimated Primary Completion Date :||October 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- embryo quality [ Time Frame: embryo quality will be analyze on day 3 and 5 after fertilization ]Number of embryo with A or B quality according to ASEBIR (Spanish association for the study of the biology of reproduction) criteria
- Pregnancy rate [ Time Frame: between 14-16 days after fertilization ]serum levels of chorionic gonadotropin Beta (Beta-hCG)
- ongoing pregnancy [ Time Frame: 16-18 week after fertilization ]ultrasonography
- implantation rate [ Time Frame: 24 days after fertilization ]number of embryos implanted/number of embryos transferred x100
- pregnancy loss rate [ Time Frame: 10 days after B-hCG evaluation at end of pregnancy ]number of miscarriages/ number of ongoing pregnancy x100
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436758
|Contact: Juan C Martinez-Soto, PhD||+34968200031 ext firstname.lastname@example.org|
|Contact: Marta Mollá, BD||+34968200031 ext email@example.com|
|Murcia, Spain, 30007|
|Contact: Juan Carlos Martinez Soto, MD, PhD +34666676183 JuanCarlos.Martinez@ivi.es|
|Principal Investigator:||Jose Landeras, MD||IVI-RMA|