Egg Freezing Pilot Study
Oocyte Cryopreservation in Assisted Reproduction
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 9, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedDecember 3, 2015
December 1, 2015
1.3 years
February 9, 2009
December 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Biochemical Pregnancy
1 year
Secondary Outcomes (4)
Recovery of viable oocytes
1 year
incidence of fertilization
one year
embryo development (how many fertilized eggs undergo development to a more advanced stage)
1 year
clinical pregnancy (fetal pole visible on transvaginal ultrasound) per cycle
1 year
Study Arms (1)
Oocyte Vitrification
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current pregnancy
- Patients with significant anemia (Hemoglobin \< 10 mg/dL).
- Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Reproductive Associates
Hasbrouck Heights, New Jersey, 07604, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter G. McGovern, MD
UMDNJ-NJMS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2009
First Posted
February 10, 2009
Study Start
February 1, 2009
Primary Completion
June 1, 2010
Study Completion
February 1, 2011
Last Updated
December 3, 2015
Record last verified: 2015-12