- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00977821
Embryo Developmental Capacity After Egg Banking in an Ovum Donation Program
For an efficient "egg banking" system, an equally efficient cryopreservation strategy that ensures the viability of the oocytes is required. Very recently, improved and new methods are yielding satisfactory results. In particular, vitrification is providing excellent results for both survival and clinical outcomes. However, to evaluate the over all out come there are other parameters to be considered. In this sense, capacity development of embryos generated after oocyte vitrification is a major factor when assessing the viability of vitrified oocytes. Accordingly, the evaluation of the capacity of vitrified oocytes to reach the blastocyst stage will be highly valuable to fully assess the effectiveness of the "egg banking" and its contribution to ovum donation programs.
The aim of this study is to evaluate the developmental capacity of vitrified oocytes by their ability to reach the blastocyst stage. The study includes oocyte donation cycles conducted with vitrified versus fresh oocytes.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
-
Valencia, Spanien, 46015
- IVI Valencia
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18-35 year old
- Normal response (8-15 follicles) to long protocol of ovarian stimulation with hCG
- Donors with normal menstrual cycles (21-35 day duration)
- Donors with BMI between 18-25 Kg/m2
Exclusion Criteria:
- Donors with two or more previous miscarriages
- Polycystic ovary syndrome
- Donors with antecedents of poor embrionary quality not attributed to masculine factor
- Donors with drop of estradiol of more than 10% or estradiol plateau.
- Donors with a high response>20 oocytes and or levels above 3000pg/ml of estradiol the day of the administration of chorionic gonadotrophin (hCG)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: fresh
Embryo transfer with fresh oocytes
|
|
|
Eksperimentel: Frozen
Embryo transfer with vitrified oocytes
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Mean outcome measures will be survival, fertilization and blastocyst rates and clinical outcome.
Tidsramme: 10 months
|
10 months
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0901-F-054-CS
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