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Oocyte Cryopreservation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01696786
First received: September 27, 2012
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Fertility Preservation
Procedure: Oocyte cryopreservation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oocyte Cryopreservation

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Survival rate of cryopreserved oocytes with each cryopreservation method [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Survival rate of cryopreserved oocytes with each cryopreservation method

  • Pregnancy rate following thawing/warming of oocytes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Pregnancy rate following thawing/warming of oocytes

  • Implantation rate per embryo transferred [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Implantation rate per embryo transferred


Estimated Enrollment: 250
Study Start Date: June 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oocyte cryopreservation Procedure: Oocyte cryopreservation
Oocyte (egg) cryopreservation (freezing) to preserve fertility

  Eligibility

Ages Eligible for Study:   up to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696786

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01696786     History of Changes
Other Study ID Numbers: 0903010292
Study First Received: September 27, 2012
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014