Single Human Embryo Transfer in Assisted Reproduction Programs (SET)
Single Human Embryo Transfer: Comparison of Morphologic and Morphometric Parameters for Day 2 Embryo Selection Before Transference.
Embryo selection based on the use of morphometric parameters should increase the implantation success rate.
One of the most important issues of "Assisted Reproduction Technologies (ART)" is the possibility of multiple pregnancies which carries a significant risk for maternal-fetal health. These risks can be reduced by restricting the number of embryos transferred.
To do this, it is essential to improve current techniques of embryo selection by developing new tools that would allow the selection of the embryos with higher implantation potential. In previous works (Molina et al 2011) the investigators have demonstrated greater efficacy for the embryo classification systems based on the use of the morphometric variables. The investigators have also developed a profile of embryo implantation using these morphometric variables. In this project the investigators intend to validate the clinical validity of this new embryo classification system by conducting a prospective study of single embryo transfer (SET) in young women at risk of multiple pregnancies.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiesteder
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Valencia, Spania, 46009
- Rekruttering
- Hospital Universitari La Fe
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Ta kontakt med:
- FUNDACION PARA LA INVESTIGACION
- Telefonnummer: +3496 386 27 58
- E-post: ceic@fundacionlafe.org
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Underetterforsker:
- Montañana Vicente, Ph.D
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Underetterforsker:
- Martinez Juan Vicente
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Underetterforsker:
- Rubio Jose Maria, Ph.D
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Underetterforsker:
- Polo Patrocinio, Ph.D
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Underetterforsker:
- Balasch Sebastian, Ph.D
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Underetterforsker:
- Garcia Trinidad, Ph.D
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Underetterforsker:
- Marzal Alicia
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Underetterforsker:
- Taronger Roser, Ph.D
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Personal and family history without interest, not toxic habits.
- Less than 35 years at the time of IVF-ICSI cycle
- Sterility of unknown origin or tubal obstruction.
Exclusion Criteria:
- Repeat nonvoluntary abortions
- Endometriosis
- Polycystic ovary syndrome (criteria Rotterdam 2004)
- Severe male factor (REM <1 million sperm / ml)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: single embryo transfer
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Prospective study of single embryo transfers in selected women with good reproductive prognosis and high risk of multiple pregnancies in an IVF-ICSI program.. The day of the embryo transfer, the patients will be randomized by a computer application for morphological and morphometric embryo selection.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Implantation rate
Tidsramme: 6 weeks after the embryo transference
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Pregnancy was defined as a gestational sac with a foetus with heart activity detected through sonography in gestational week 6-8.The implantation rate was defined as the number of gestational sacs per number of transferred embryos.
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6 weeks after the embryo transference
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Morphologic embryo selection
Tidsramme: 48 hours post insemination (day 2)
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The morphological selection will be made by direct observation of the embryo in an inverted microscope phase contrast.
Cell number, blastomere symmetry and fragmentation, and structural abnormalities of the zona pellucida (ZP)were recorded
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48 hours post insemination (day 2)
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Morphometric embryo selection
Tidsramme: 48 hours post insemination (day 2)
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Morphometric selection will be made by obtaining serial photographs of the embryo that will later be analyzed with an image analysis program that will select the best quality embryos for later transfer The images were analyzed by using ImageJ, a public program developed by Wayne Rasband (http://rsb.info.nih.gov/ij/) and their available tools.
The program was used interactively, by applying several of tools and plugins in order to determine the region of interest for the measurements.
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48 hours post insemination (day 2)
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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Jose J Pertusa, Ph.D., Director of the deparment of Biología Funcional y Análisis de Imagen
- Studieleder: Antonio A Pellicer, Ph.D., Head of Gynecology and Obstetrics
- Hovedetterforsker: Inmaculada I Molina, Ph.D., Embryologist of the Human Reproduction Unit
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2011/0329
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