Embryo Developmental Capacity After Egg Banking in an Ovum Donation Program
1 other identifier
interventional
625
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 15, 2009
CompletedFirst Posted
Study publicly available on registry
September 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedApril 22, 2015
April 1, 2015
4.7 years
September 15, 2009
April 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Mean outcome measures will be survival, fertilization and blastocyst rates and clinical outcome.
10 months
Study Arms (2)
fresh
ACTIVE COMPARATOREmbryo transfer with fresh oocytes
Frozen
EXPERIMENTALEmbryo transfer with vitrified oocytes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IVI Valencia
Valencia, 46015, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Carlos Simon MD PhD
Study Record Dates
First Submitted
September 15, 2009
First Posted
September 16, 2009
Study Start
September 1, 2009
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
April 22, 2015
Record last verified: 2015-04