Embryo Developmental Capacity After Egg Banking in an Ovum Donation Program

Phase 4

Completed

• Conditions: Infertility
• Interventions: Other: Oocyte Vitrification; Other: IVF

• Registration Number: NCT00977821
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 625

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Frozen	Oocyte Vitrification	Embryo transfer with vitrified oocytes
fresh	IVF	Embryo transfer with fresh oocytes

Primary Outcome Measures

Name	Time	Method
Mean outcome measures will be survival, fertilization and blastocyst rates and clinical outcome.	10 months

Trial Locations

Locations (1)

IVI Valencia; 🇪🇸 Valencia, Spain