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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
Sponsor:
Collaborator:
Universidad de Murcia
Information provided by (Responsible Party):
IVI Murcia

Brief Summary:

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.


Condition or disease
Infertility

Detailed Description:
  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


Study Type : Observational
Estimated Enrollment : 27 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: between 14-16 days after fertilization ]
    serum levels of chorionic gonadotropin Beta (Beta-hCG)

  2. ongoing pregnancy [ Time Frame: 16-18 week after fertilization ]
    ultrasonography

  3. implantation rate [ Time Frame: 24 days after fertilization ]
    number of embryos implanted/number of embryos transferred x100

  4. 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
uterine fluid


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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
infertility couples
Criteria

Inclusion Criteria:

  • Couples in icsi treatment

Woman:

BMI between 17 and 30.Under controlled ovarian stimulation and at least 8 metaphase II oocytes collected

Man:

Sperm concentration higher than 5 million sperm / ml

Exclusion Criteria:

  • Woman:

Diagnosis of endometriosis Uterine pathology that compromises embryonic development Patients undergoing treatment for repeat abortion or implantation failures Abnormal karyotype Patients included in the Pre-Implantation Genetic Diagnosis (DPI) program

Male:

Men whit abnormal karyotype, High values of DNA fragmentation Abnormal FISH (Fluorescence in situ Hybridization) Sperm from epididymal aspirate or testicular biopsy


Information from the National Library of Medicine

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


Contacts
Contact: Juan C Martinez-Soto, PhD +34968200031 ext 16523 juancarlos.martinez@ivi.es
Contact: Marta Mollá, BD +34968200031 ext 16519 marta.molla@ivi.es

Locations
Spain
IVI Murcia Recruiting
Murcia, Spain, 30007
Contact: Juan Carlos Martinez Soto, MD, PhD    +34666676183    JuanCarlos.Martinez@ivi.es   
Sponsors and Collaborators
IVI Murcia
Universidad de Murcia
Investigators
Principal Investigator: Jose Landeras, MD IVI-RMA

Publications of Results:
Other Publications:
Responsible Party: IVI Murcia
ClinicalTrials.gov Identifier: NCT03436758     History of Changes
Other Study ID Numbers: 1607-MUR-055-JL
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by IVI Murcia:
uterine fluids
Biobank
culture medium

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female