NCT03436758

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. 1.Creation of the first collection of human uterine fluid samples for Assisted Reproduction use.
  2. 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

February 12, 2018

Last Update Submit

February 12, 2018

Conditions

Infertility

Keywords

uterine fluidsBiobankculture medium

Outcome Measures

Primary Outcomes (1)

  • embryo quality

    Number of embryo with A or B quality according to ASEBIR (Spanish association for the study of the biology of reproduction) criteria

    embryo quality will be analyze on day 3 and 5 after fertilization

Secondary Outcomes (4)

  • Pregnancy rate

    between 14-16 days after fertilization

  • ongoing pregnancy

    16-18 week after fertilization

  • implantation rate

    24 days after fertilization

  • pregnancy loss rate

    10 days after B-hCG evaluation at end of pregnancy

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

infertility couples

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Murcia

Murcia, 30007, Spain

RECRUITING

Related Publications (7)

  • Coy P, Jimenez-Movilla M, Garcia-Vazquez FA, Mondejar I, Grullon L, Romar R. Oocytes use the plasminogen-plasmin system to remove supernumerary spermatozoa. Hum Reprod. 2012 Jul;27(7):1985-93. doi: 10.1093/humrep/des146. Epub 2012 May 3.

    PMID: 22556378BACKGROUND

  • Aviles M, Gutierrez-Adan A, Coy P. Oviductal secretions: will they be key factors for the future ARTs? Mol Hum Reprod. 2010 Dec;16(12):896-906. doi: 10.1093/molehr/gaq056. Epub 2010 Jun 28.

    PMID: 20584881RESULT

  • Belva F, Bonduelle M, Roelants M, Michielsen D, Van Steirteghem A, Verheyen G, Tournaye H. Semen quality of young adult ICSI offspring: the first results. Hum Reprod. 2016 Dec;31(12):2811-2820. doi: 10.1093/humrep/dew245. Epub 2016 Oct 5.

    PMID: 27707840RESULT

  • Chiu PC, Chung MK, Koistinen R, Koistinen H, Seppala M, Ho PC, Ng EH, Lee KF, Yeung WS. Cumulus oophorus-associated glycodelin-C displaces sperm-bound glycodelin-A and -F and stimulates spermatozoa-zona pellucida binding. J Biol Chem. 2007 Feb 23;282(8):5378-88. doi: 10.1074/jbc.M607482200. Epub 2006 Dec 27.

    PMID: 17192260RESULT

  • Coy P, Canovas S, Mondejar I, Saavedra MD, Romar R, Grullon L, Matas C, Aviles M. Oviduct-specific glycoprotein and heparin modulate sperm-zona pellucida interaction during fertilization and contribute to the control of polyspermy. Proc Natl Acad Sci U S A. 2008 Oct 14;105(41):15809-14. doi: 10.1073/pnas.0804422105. Epub 2008 Oct 6.

    PMID: 18838686RESULT

  • Coy P, Grullon L, Canovas S, Romar R, Matas C, Aviles M. Hardening of the zona pellucida of unfertilized eggs can reduce polyspermic fertilization in the pig and cow. Reproduction. 2008 Jan;135(1):19-27. doi: 10.1530/REP-07-0280.

    PMID: 18159080RESULT

  • Gabler C, Chapman DA, Killian GJ. Expression and presence of osteopontin and integrins in the bovine oviduct during the oestrous cycle. Reproduction. 2003 Dec;126(6):721-9.

    PMID: 14748691RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

uterine fluid

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Jose Landeras, MD

    IVI-RMA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan C Martinez-Soto, PhD

CONTACT

+34968200031juancarlos.martinez@ivi.es

Marta Mollá, BD

CONTACT

+34968200031marta.molla@ivi.es

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 19, 2018

Study Start

January 30, 2018

Primary Completion

October 30, 2019

Study Completion

December 31, 2019

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)