Oocyte Cryopreservation by Slow Freezing and Vitrification

Phase 2

Terminated

• Conditions: Women Diagnosed With Cancer; Egg Donors; Single Women; Failed Sperm Procurement in IVF
• Interventions: Procedure: slow freeze; Procedure: Vitrification

• Registration Number: NCT01223105
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Slow Freezing	slow freeze	oocytes will be frozen by slow freeze/ rapid thaw
Vitrification	Vitrification	oocytes will be frozen using rapid freezing/rapid thaw

Primary Outcome Measures

Name	Time	Method
Oocytes survival after thaw	1 month	Whether each oocyte survives the thawing process

Secondary Outcome Measures

Name	Time	Method
Fertilization	1 month	Whether each oocyte is successfully fertilized
Implantation	1 month	Whether pregnancy occurs.