Oocyte Cryopreservation

The specific aim of this study is to further develop methods of oocyte cryopreservation and evaluate their impact on reproductive outcomes.

Study Overview

• Status: Completed
• Conditions: Fertility Preservation
• Intervention / Treatment: Procedure: Oocyte cryopreservation

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 42 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Any consenting female who wishes to freeze unfertilized oocytes and are:

1. at risk for ovarian hyperstimulation syndrome (enlarged ovaries with abdominal fluid accumulation) and postponement of pregnancy has been recommended.
2. a cancer patient anticipating treatment and have been cleared by the oncologists for ovarian stimulation.
3. a female who seeks to preserve her future fertility and does not wish to use donor or partner sperm to fertilize her eggs.
4. a donor egg recipient who elects to have some of the eggs obtained fertilized with husband/partner sperm and the rest cryopreserved for future use.
5. a patient for whom the partner's sperm retrieval or production has failed and donor sperm is not an option.
6. a patient who, for religious or ethical reasons, wants to limit the number of fresh oocytes exposed to sperm (fertilization) and do not want to either discard or donate the excess oocytes.

AND

1. has been clinically and psychologically approved for ovarian stimulation
2. age between 12 and 42 years, inclusive, at time of informed consent.
3. willing and able to comply with the protocol.
4. willing to provide follow-up information from her OB/GYN of any CVS/amniocentesis results, as well as information on obstetrical outcome.
5. agree to undergo intracytoplasmic sperm injection (ICSI) when oocytes are thawed.

For cancer patients:

1. No significant ovarian pathology as judged by physical exam and radiological studies;
2. Patient's general condition and prognosis deemed favorable for surgery and chemo/radio therapy;
3. No other major medical illness,
4. Oncologist approval for the ovarian stimulation and egg retrieval.

Exclusion Criteria:

Age > 42 Subjects who do not meet the inclusion criteria will be ineligible for participation in this 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 cryopreservation	Procedure: Oocyte cryopreservation; Oocyte (egg) cryopreservation (freezing) to preserve fertility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate of cryopreserved oocytes with each cryopreservation method	Survival rate of cryopreserved oocytes with each cryopreservation method	1 year
Pregnancy rate following thawing/warming of oocytes	Pregnancy rate following thawing/warming of oocytes	1 year
Implantation rate per embryo transferred	Implantation rate per embryo transferred	1 year

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2009
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): October 1, 2012

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 0903010292