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A Comparison of Two Freezing Techniques

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
oocyte freezing
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility focused on measuring oocyte freezing, vitrification, slow freeze, fertility preservation

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • North Shore University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

slow freeze

vitrification

Arm Description

these recipients will have their first embryo transfer with oocytes frozen via the slow freeze method.

these recipients will have their first attempt at an embryo transfer with oocytes frozen via the vitrification method.

Outcomes

Primary Outcome Measures

Achievement of a pregnancy, as determined by a fetal heartbeat

Secondary Outcome Measures

Percentage of eggs that result in blastocyst formation
Oocyte survival (the percentage of eggs that survive the freeze-thaw procedure)
ICSI fertilization rate (percentage of eggs that fertilize)
Incidence rate of embryo formation (percentage of embryos formed/number of eggs fertilized)

Full Information

First Posted
February 25, 2009
Last Updated
October 8, 2012
Sponsor
Northwell Health
Collaborators
EMD Serono
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1. Study Identification

Unique Protocol Identification Number
NCT00852306
Brief Title
A Comparison of Two Freezing Techniques
Official Title
A Comparison of Two Freezing Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
Collaborators
EMD Serono

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
oocyte freezing, vitrification, slow freeze, fertility preservation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
slow freeze
Arm Type
Experimental
Arm Description
these recipients will have their first embryo transfer with oocytes frozen via the slow freeze method.
Arm Title
vitrification
Arm Type
Experimental
Arm Description
these recipients will have their first attempt at an embryo transfer with oocytes frozen via the vitrification method.
Intervention Type
Procedure
Intervention Name(s)
oocyte freezing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Achievement of a pregnancy, as determined by a fetal heartbeat
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Percentage of eggs that result in blastocyst formation
Time Frame
1 week
Title
Oocyte survival (the percentage of eggs that survive the freeze-thaw procedure)
Time Frame
2 days
Title
ICSI fertilization rate (percentage of eggs that fertilize)
Time Frame
2 days
Title
Incidence rate of embryo formation (percentage of embryos formed/number of eggs fertilized)
Time Frame
2 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avner Hershlag, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Cohen, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huai L Feng, PhD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

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A Comparison of Two Freezing Techniques

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