- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01033474
Results Following the Vitrification of Human Oocytes Using 2 Methodologies
Embryonic Developmental Rates and Pregnancies Following the Vitrification of Human Oocytes Using Two Methodologies.
The investigators are going to compare embryo developmental rates of human eggs following freezing in two different freezing methods. The investigators are going to compare the pregnancy rates following transfer to patients as well.
Null Hypothesis: The type of vitrification methodology used will not have an impact on the following:
- Survival rates
- Embryonic developmental rates
- Pregnancy and implantation rates.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Randomization of Oocytes: Oocytes will be denuded approximately 1-2 hours post retrieval and graded for maturity. Only the Metaphase II oocyte will be vitrified. Half of the oocytes within each donor will be randomized to the following treatments.
- Frozen using an open system using a metal grid to hold the oocyte. Three to five oocytes will be frozen on the metal grid using a minute amount (< 2-3 µls) of cryoprotectant. A top is put over the metal grid to protect the oocytes. This system has proven to be successful in limited cases in Peru. This is an open system of vitrification where the oocytes are directly plunged into liquid nitrogen. This will serve as the control.
- Frozen in closed straws using a methodology developed by Jim Stachecki. Three to five oocytes will be frozen in ¼ cc straws. This is very similar to the method used to successfully vitrify blastocysts. This will be the experimental treatment.
Null Hypothesis: The type of vitrification methodology used will not have an impact on the following:
- Survival rates
- Embryonic developmental rates
Pregnancy and implantation rates. Measured Outcomes The effect of vitrification technique will be measured using the appropriate statistical analysis on the following parameters.
- Survival rates following thawing.
- Effect of vitrification technique on how oocytes react to ICSI. The parameters have been previously defined at NCRS.
- Normal fertilization rates, abnormal fertilization rates and rates of degeneration following ICSI.
- Embryonic development rates. Embryos will be cultured until Day 5/6 and rate as well as quality of blastocyst will be noted.
- Pregnancy and implantation rates following replacement in endometrial prepared recipients.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Lima, Pérou
- Laboratorio de Reproducción Asistida
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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
La description
Inclusion Criteria:
- Must be healthy and pass testing as per clinic standards
Exclusion Criteria:
- Are over the age or cannot carry a pregnancy safely
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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donor eggs
|
infertile patients
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Que mesure l'étude ?
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Pregnancy rate
Délai: 12 weeks
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12 weeks
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 555-2009
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