Embryo Developmental Capacity After Egg Banking in an Ovum Donation Program

Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977821
• Other study ID #: 0901-F-054-CS
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2009
• Last updated: April 21, 2015
• Start date: September 2009
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 625
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• IVF

• Oocyte Vitrification

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean outcome measures will be survival, fertilization and blastocyst rates and clinical outcome.		10 months	No