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Longitudinal Evaluation of Vitrification of Human Oocytes


Phase 2/Phase 3
21 Years
50 Years
Not Enrolling
Female
Women Diagnosed With Cancer, Egg Donors, Single Women, Failed Sperm Procurement in IVF

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Trial Information

Longitudinal Evaluation of Vitrification of Human Oocytes


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Oocytes survival after thaw

Outcome Description:

Whether each oocyte survives the thawing process

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Richard T Scott, MD, HCLD

Investigator Role:

Study Director

Investigator Affiliation:

RMA of NJ

Authority:

United States: Institutional Review Board

Study ID:

RMA-2009-02

NCT ID:

NCT01223105

Start Date:

July 2009

Completion Date:

July 2011

Related Keywords:

  • Women Diagnosed With Cancer
  • Egg Donors
  • Single Women
  • Failed Sperm Procurement in IVF
  • slow freeze
  • cryopreservation
  • vitrification
  • oocyte preservation

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