Oocyte Cryopreservation by Slow Freezing and Vitrification

NCT ID: NCT01223105

Last Updated: 2013-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-07-31

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.

Detailed Description

Cryopreservation (freezing) of human gametes (unfertilized egg) provides a great potential to preserve or extend fertility in the face of disease and social circumstances (cancer diagnosis, delaying childbirth, single women, etc.). There are two methods for storage of oocytes (unfertilized eggs): slow freezing or vitrification (uses higher concentrations of cryoprotectant and faster cooling rates). Slow freezing is the standard method and has been successful for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. The aim of this study is to examine the rate at which frozen eggs survive freezing and thawing, the rate at which the frozen/thawed eggs fertilize with sperm and the pregnancy outcomes of oocyte (egg) vitrification cycles to determine whether the outcomes are similar or better than standard oocyte (egg) cryopreservation (freezing) cycles.

Conditions

Women Diagnosed With Cancer; Egg Donors; Single Women; Failed Sperm Procurement in IVF

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Slow Freezing

oocytes will be frozen by slow freeze/ rapid thaw

Group Type: EXPERIMENTAL

slow freeze

Intervention Type: PROCEDURE

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

Vitrification

oocytes will be frozen using rapid freezing/rapid thaw

Group Type: EXPERIMENTAL

Vitrification

Intervention Type: PROCEDURE

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

Interventions

slow freeze

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

Intervention Type: PROCEDURE

Vitrification

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

Intervention Type: PROCEDURE

Other Intervention Names

Cryopreservation; Traditional freezing; slow freezing

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard T Scott, MD, HCLD

Role: STUDY_DIRECTOR

RMA of NJ

Kathleen Ferry, BS

Role: STUDY_CHAIR

RMA of NJ

Other Identifiers

RMA-2009-02

Identifier Type: -

Identifier Source: org_study_id