Egg Freezing Pilot Study - Full Text View

Sponsored by:	University Reproductive Associates
Information provided by:	University Reproductive Associates
ClinicalTrials.gov Identifier:	NCT00839839

Purpose

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.

Condition	Intervention
Infertility Egg Freezing	Procedure: Oocyte Vitrification

MedlinePlus related topics: Infertility

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Oocyte Cryopreservation in Assisted Reproduction

Further study details as provided by University Reproductive Associates:

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

Estimated Enrollment:	10
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839839

Contacts

Contact: Amy Solnica, MSN RN	973-972-3633	solnicam@umdnj.edu
Contact: Peter G. McGovern, MD	201-288-6330	mcgovepg@umdnj.edu

Locations

United States, New Jersey
University Reproductive Associates	Recruiting
Hasbrouck Heights, New Jersey, United States, 07604
Principal Investigator: Peter G. McGovern, MD

Sponsors and Collaborators

University Reproductive Associates

Investigators

Principal Investigator:

Peter G. McGovern, MD

UMDNJ-NJMS

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UMDNJ-NJMS ( Peter G. McGovern, MD )
Study ID Numbers:	IRB 0120080226
Study First Received:	February 9, 2009
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00839839 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University Reproductive Associates:

infertility
egg freezing
fertility preservation

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Genital Diseases, Male

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 06, 2009