Egg Freezing Pilot Study

Oocyte Cryopreservation in Assisted Reproduction

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Egg Freezing
• Intervention / Treatment: Procedure: Oocyte Vitrification

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hasbrouck Heights, New Jersey, United States, 07604
      • University Reproductive Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. 10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form.
2. In good general health off of current medications which may confound response to study medications.
3. Desire to seek pregnancy actively during the study period by IVF-ICSI.
4. A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
5. Ability to use the required medications.
6. Day 3 FSH level < 12 IU/ml

Exclusion Criteria:

1. Current pregnancy
2. Patients with significant anemia (Hemoglobin < 10 mg/dL).
3. Patients enrolled simultaneously into other investigative studies that would interfere with this research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oocyte Vitrification	Procedure: Oocyte Vitrification; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Biochemical Pregnancy	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Reproductive Associates
• Investigators: Principal Investigator: Peter G. McGovern, MD, Umdnj-Njms

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 9, 2009
• First Submitted That Met QC Criteria: February 9, 2009
• First Posted (Estimate): February 10, 2009

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: infertility; egg freezing; fertility preservation
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: IRB 0120080226

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No