A Comparison of Two Freezing Techniques

This study has been completed.
Sponsor:
Collaborator:
EMD Serono
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00852306
First received: February 25, 2009
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to determine the best way to freeze eggs in order to preserve the fertility potential of young women.


Condition Intervention
Infertility
Procedure: oocyte freezing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Comparison of Two Freezing Techniques

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Achievement of a pregnancy, as determined by a fetal heartbeat [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of eggs that result in blastocyst formation [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Oocyte survival (the percentage of eggs that survive the freeze-thaw procedure) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • ICSI fertilization rate (percentage of eggs that fertilize) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Incidence rate of embryo formation (percentage of embryos formed/number of eggs fertilized) [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: February 2009
Study Completion Date: October 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: slow freeze
these recipients will have their first embryo transfer with oocytes frozen via the slow freeze method.
Procedure: oocyte freezing
retrieved oocytes from the donor will be split in half and frozen by both existing egg freezing methods: slow freezing and vitrification. The recipients will then be randomized as to which group of eggs will be thawed out for their first attempt at achieving a pregnancy.
Experimental: vitrification
these recipients will have their first attempt at an embryo transfer with oocytes frozen via the vitrification method.
Procedure: oocyte freezing
retrieved oocytes from the donor will be split in half and frozen by both existing egg freezing methods: slow freezing and vitrification. The recipients will then be randomized as to which group of eggs will be thawed out for their first attempt at achieving a pregnancy.

Detailed Description:

Human egg freezing is rapidly becoming a vital tool in Assisted Reproductive Technology. Candidates for egg freezing include women without partners who wish to preserve their fertility; cancer patients at risk of losing fertility from chemotherapy; and donor egg recipients. While in the past, egg freezing has not been as successful as embryo freezing in producing live births, recent experience in several centers has demonstrated significant improvement, with pregnancy rates comparable to those achieved with frozen embryos. The purpose of this study is to determine the best method to freeze eggs. We shall be seeking volunteers from the egg donor program, since young, fertile donors represent the best model to study the effect of egg freezing.

We plan to enroll 12 recipients and 6 donors in this study. Each egg donor will go through a stringent screening process (medical, genetic and psychological). Eggs retrieved from all donors will be split in half: one half will be frozen by the slow freeze method, and the other half by vitrification. Each of the six donors will be paired with two recipients; each recipient will be assigned half the total eggs frozen. For each recipient, half of the eggs will come from the slow freeze group and the other half will come from vitrification.

When the recipient's uterine lining is deemed ready (following estrogen treatment and ultrasound monitoring), thawing will be performed on eggs frozen by either the slow freeze or the vitrification method. The thaw process will be randomized between the two types of freezing. One sperm will be injected into each egg that survived the freeze. Fertilization and embryo development will be recorded. Ideally, two embryos will be transferred into the recipient's uterus. Pregnancy will be determined by a blood test and followed by serial blood tests and ultrasound.

The study will determine which freezing method yields better survival and pregnancy rates.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • donors: women ages 21-32 who wish to donate their eggs; must pass medical, physical and psychological screening.
  • recipients: women under the age of 50 who wish to have eggs donated to them through the Donor Egg Program and who aslo pass the medical, physical and psychological screening.

Exclusion Criteria:

  • donors: those who do not pass the genetic screening or psychological testing, as described below
  • recipients: those who do not pass the screening.

The genetic screening of donors will involve the following:

  • All donors will be screened for Cystic Fibrosis, Fragile X and Spinomuscular Atrophy (SMA).
  • In addition, donors of Ashkenazi Jewish origin will be screened for Gaucher's disease, Canavan,Tay -Sachs, Familial Dysautonomia, Niemann Pick, Fanconi's Anemia, Bloom and Mucolipidosis Type IV.
  • Donors of African-American origin will be screened for Sickle-Cell disease.
  • Donors of Asian, Mediterranean, Latino or Hispanic origins will be screened for Thalassemia.

Recipient Screening: A Reproductive Endocrinologist (RE) at the Center will take a detailed history and perform a physical examination on all potential recipients. The RE will assess the health of the potential recipient in order to assess her capacity to carry a pregnancy. Previous IVF cycles, successful or unsuccessful, will have no implication on recipient selection.

The recipient and her partner (if applicable) will meet with the program psychologist. The psychological evaluation is detailed below.

Psychological evaluation: A psychological evaluation will be conducted of the Recipient, her partner (if applicable) and the Donor. The purpose of these evaluations is to determine the suitability of the parties to participate in the Donor Egg Program. Psychological tests will be administered by the Center as part of the evaluation process.

These evaluations may result in a recommendation that one and/or all of the parties not participate in the Donor Egg Program. The psychologist will not be providing any advice or treatment to the Donor or Recipient(s). Nor will the Donor or Recipient(s) be entitled to the results of the Psychologist's evaluation. The Psychologist will provide the results of his/her evaluations to the Center for Human Reproduction.

As with our standard Donor Egg Program practices, there will be an upper age limit of 50 years for all recipients participating in the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852306

Locations
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
North Shore Long Island Jewish Health System
EMD Serono
Investigators
Principal Investigator: Avner Hershlag, MD North Shore Long Island Jewish Health System
Principal Investigator: Matthew Cohen, MD North Shore Long Island Jewish Health System
Principal Investigator: Huai L Feng, PhD North Shore Long Island Jewish Health System
  More Information

Publications:
Diaz DG, Rodriguez-Karl MC and Moody JE (2007) Human oocyte cryopreservation: preliminary results of survival, fertilization and cleavage rate of frozen oocyte using a new modified slow-freeze protocol. Fertil Steril 88, Suppl 1:S47.
Fioravanti J, Alegretti JR, Hassun PA, Motta ELA, Serafini PC and Smith GD (2007) Prospective randomized comparison of human oocyte freezing and vitrification: an update. Fertil Steril 88, Suppl 1:S13
Kumayama M and Kato O (2000a) Successful vitrification of human oocytes. Fertil Steril 74, Suppl 3:S49.
Kumayama M and Kato O (2000b) All-round vitrification method for human oocytes and embryos. J Asst Reprod Gen 17:447.
Kuzan FB and Quinn P (1988) Cryopreservation of mammalian embryos IN in vitro fertilization and embryo transfer: a manual of basic techniques. Plenum Press, New York.
Nagy ZP, Chang CC, Shapiro D, Elsner C, Mitchell-Leef D and Kort H (2007) Clinical evaluation of the efficiency of oocyte donation program using egg cryo-banking. Fertil Steril 88, Suppl 1:S42.

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00852306     History of Changes
Other Study ID Numbers: 08-265
Study First Received: February 25, 2009
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
oocyte freezing
vitrification
slow freeze
fertility preservation

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 20, 2014