- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03436758
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,:
- 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
- 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
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Murcia, Spagna, 30007
- Reclutamento
- IVI Murcia
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
embryo quality
Lasso di tempo: 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
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embryo quality will be analyze on day 3 and 5 after fertilization
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Pregnancy rate
Lasso di tempo: between 14-16 days after fertilization
|
serum levels of chorionic gonadotropin Beta (Beta-hCG)
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between 14-16 days after fertilization
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ongoing pregnancy
Lasso di tempo: 16-18 week after fertilization
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ultrasonography
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16-18 week after fertilization
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implantation rate
Lasso di tempo: 24 days after fertilization
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number of embryos implanted/number of embryos transferred x100
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24 days after fertilization
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pregnancy loss rate
Lasso di tempo: 10 days after B-hCG evaluation at end of pregnancy
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number of miscarriages/ number of ongoing pregnancy x100
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10 days after B-hCG evaluation at end of pregnancy
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jose Landeras, MD, IVI-RMA
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1607-MUR-055-JL
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