NCT01223105

Brief Summary

This study seeks to evaluate whether the vitrification technique, as compared to the more traditional slow-cooling technique, leads to higher rates of successful thawing, fertilization, implantation and delivery.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2

Status
terminated

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

July 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

October 8, 2010

Last Update Submit

November 18, 2013

Conditions

Women Diagnosed With CancerEgg DonorsSingle WomenFailed Sperm Procurement in IVF

Keywords

slow freezecryopreservationvitrificationoocyte preservation

Outcome Measures

Primary Outcomes (1)

  • Oocytes survival after thaw

    Whether each oocyte survives the thawing process

    1 month

Secondary Outcomes (2)

  • Fertilization

    1 month

  • Implantation

    1 month

Study Arms (2)

Slow Freezing

EXPERIMENTAL

oocytes will be frozen by slow freeze/ rapid thaw

Procedure: slow freeze

Vitrification

EXPERIMENTAL

oocytes will be frozen using rapid freezing/rapid thaw

Procedure: Vitrification

Interventions

slow freezePROCEDURE

Eggs will be placed in a cryo-protected solution and frozen slowly in a programable freezer

Also known as: Cryopreservation, Traditional freezing, slow freezing
Slow Freezing
VitrificationPROCEDURE

Eggs will be placed in a high concentration of cryo-protectant and frozen very quickly by plunging in liquid nitrogen

Vitrification

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 21 and 50 years, at the time of informed consent.
  • Subjects must agree to undergo intracytoplasmic sperm injection (ICSI)

You may not qualify if:

  • Presence of any medical condition that contraindicates ovarian stimulation, in vitro fertilization or pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

CryopreservationVitrification

Intervention Hierarchy (Ancestors)

Tissue PreservationHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesPreservation, BiologicalTherapeuticsInvestigative TechniquesPhase TransitionPhysical Phenomena

Study Officials

  • Richard T Scott, MD, HCLD

    RMA of NJ

    STUDY DIRECTOR

  • Kathleen Ferry, BS

    RMA of NJ

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 18, 2010

Study Start

July 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 19, 2013

Record last verified: 2013-11