Oocyte Cryopreservation by Slow Freezing and Vitrification

Condition(s) targeted: Women Diagnosed With Cancer; Egg Donors; Single Women; Failed Sperm Procurement in IVF

Intervention: slow freeze (Procedure); Vitrification (Procedure)

Phase: Phase 2/Phase 3

Status: Terminated

Sponsored by: Reproductive Medicine Associates of New Jersey

Official(s) and/or principal investigator(s):
Richard T Scott, MD, HCLD, Study Director, Affiliation: RMA of NJ
Kathleen Ferry, BS, Study Chair, Affiliation: RMA of NJ

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.

Official title: Longitudinal Evaluation of Vitrification of Human Oocytes

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Oocytes survival after thaw

Secondary outcome:

Fertilization

Implantation

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.

Minimum age: 21 Years. Maximum age: 50 Years. Gender(s): Female.

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.

Reproductive Medicine Associates of New Jersey

Starting date: July 2009
Last updated: November 18, 2013