Back to resultsEgg Freezing Pilot Study
Primary Purpose
Infertility, Egg Freezing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oocyte Vitrification
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring infertility, egg freezing, fertility preservation
Eligibility Criteria
Inclusion Criteria:
- 10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form.
- In good general health off of current medications which may confound response to study medications.
- Desire to seek pregnancy actively during the study period by IVF-ICSI.
- A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
- Ability to use the required medications.
- Day 3 FSH level < 12 IU/ml
Exclusion Criteria:
- Current pregnancy
- Patients with significant anemia (Hemoglobin < 10 mg/dL).
- Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
Sites / Locations
- University Reproductive Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oocyte Vitrification
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Biochemical Pregnancy
Secondary Outcome Measures
Recovery of viable oocytes
incidence of fertilization
embryo development (how many fertilized eggs undergo development to a more advanced stage)
clinical pregnancy (fetal pole visible on transvaginal ultrasound) per cycle
Full Information
NCT ID
NCT00839839
First Posted
February 9, 2009
Last Updated
December 1, 2015
Sponsor
University Reproductive Associates
1. Study Identification
Unique Protocol Identification Number
NCT00839839
Brief Title
Egg Freezing Pilot Study
Official Title
Oocyte Cryopreservation in Assisted Reproduction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Reproductive Associates
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
University Reproductive Associates is conducting a pilot study to study the technique of egg freezing. Your participation in this study will provide us with important information to allow us to offer this technology for women wishing to freeze their eggs before cancer treatments. Your participation will include a standard IVF cycle with your eggs being frozen for a brief period of time and then transferred back to you as usual. You will receive a significant reduction in your IVF cycle cost.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Egg Freezing
Keywords
infertility, egg freezing, fertility preservation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oocyte Vitrification
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Oocyte Vitrification
Intervention Description
All oocytes retrieved will be vitrified (rapidly frozen) after egg retrieval. The oocytes will then be warmed on the same day and fertilized per standard IVF-ICSI. Resulting embryos will be transferred back to the patient as per protocol.
Primary Outcome Measure Information:
Title
Incidence of Biochemical Pregnancy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Recovery of viable oocytes
Time Frame
1 year
Title
incidence of fertilization
Time Frame
one year
Title
embryo development (how many fertilized eggs undergo development to a more advanced stage)
Time Frame
1 year
Title
clinical pregnancy (fetal pole visible on transvaginal ultrasound) per cycle
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form.
In good general health off of current medications which may confound response to study medications.
Desire to seek pregnancy actively during the study period by IVF-ICSI.
A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
Ability to use the required medications.
Day 3 FSH level < 12 IU/ml
Exclusion Criteria:
Current pregnancy
Patients with significant anemia (Hemoglobin < 10 mg/dL).
Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter G. McGovern, MD
Organizational Affiliation
UMDNJ-NJMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Reproductive Associates
City
Hasbrouck Heights
State/Province
New Jersey
ZIP/Postal Code
07604
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.uranj.com
Description
Related Info
Learn more about this trial
Egg Freezing Pilot Study
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