- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01287273
The Impact of Early Embryos Incubation on Pregnancy Rate in IVF (IVF-2010)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
It has been common practice to cryopreserve surplus embryos achieved during IVF treatment or in other situation that embryos are to be preserved for other situations such as suspected ovarian hyper stimulation syndrome, fertility preservation or patient request.
Embryos are usually frozen on day 2, 3 or day 5-6 at the Blastocyst stage. At the time that thawing is planned, patients' cycle is synchronized and prepared either with hormonal treatment or at the natural cycle.
Not all embryos will always survive the thawing and sometimes they will all degenerate.
Embryos that survive the thawing procedure are assessed and replaced on the day of the thaw or left overnight for better selection and will be replaced only if they continue to divide in vitro.
The advantage of embryo transfer on the day of thaw is that embryo exposure in culture is shortened and embryo selection will be occurring in the womb. On the other hand, overnight incubation may avoid transferring embryos that potentially are not able to divide and are biologically not viable.
Although both attitudes are practiced in different IVF centers, at present there are no prospective randomized studies that have been conducted to advise which intervention is better in terms of pregnancy rates.
The purpose of the present study is to assess which technique will result in better pregnancy rates.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Haifa, Israël, 34362
- Recrutement
- Carmel Medical Center
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Contact:
- Martha Dirnfeld, MD
- Numéro de téléphone: 9724 8250335
- E-mail: dirnfeld_martha@clalit.org.il
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Contact:
- Shirly Lahav-Baratz, D.Sc
- Numéro de téléphone: 9724 8250118
- E-mail: lahav_shirly@clalit.org.il
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Chercheur principal:
- Martha Dirnfeld, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
660 IVF patients. patients who are candidates for embryo cryopreservation cycle will be offered to participate in the present prospective randomized study.
After detailed verbal and written explanation on the study protocol they will sign an informed consent and then randomized to 2 groups.
La description
Inclusion Criteria:
- IVF patient who have thawed embryo transfer and can read understand and sigh on informed consent
Exclusion Criteria:
- IVF patient who have thawed embryo transfer and can not read understand and sigh on informed consent/ also those whos embryos will not survive freezing- thawing
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Group A
Transfer at the day of embryo thawing
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Group B
Transfer of thawed embryos 24-72 hours post thawing
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pregnancy as measured by blood test for beta hCG
Délai: 12 days following embryos transfer
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as the usual routine, the women come on day 12 or 13 following embryo transfer to pur IVF unit to get blood teat for beta hCG.
When the result show that the beta hCG is above 5 unit/liter we consider it as positive result and the patients is invited for additional blood test 2 days later/
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12 days following embryos transfer
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Delivery of baby
Délai: 9 mounth after embryos transfer
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We are routinely report to the Israeli ministry of health all the children who were born from our treatment.
In this study we will calculate the number of children per thawed embryo transfer.
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9 mounth after embryos transfer
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Martha Dirnfeld, MD, Carmel Medical Center IVF Unit
Publications et liens utiles
Publications générales
- Lahav-Baratz S, Koifman M, Shiloh H, Ishai D, Wiener-Megnazi Z, Dirnfeld M. Analyzing factors affecting the success rate of frozen-thawed embryos. J Assist Reprod Genet. 2003 Nov;20(11):444-8. doi: 10.1023/b:jarg.0000006705.46147.a2.
- Lahav-Baratz S, Shiloh H, Koifman M, Kraiem Z, Wiener-Megnazi Z, Ishai D, Dirnfeld M. Early embryo-endometrial signaling modulates the regulation of matrix metalloproteinase-3. Fertil Steril. 2004 Oct;82 Suppl 3:1029-35. doi: 10.1016/j.fertnstert.2004.06.026.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CMC-10-0010-CTIL
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