Oocyte Cryopreservation
1 other identifier
interventional
250
1 country
1
Brief Summary
The specific aim of this study is to further develop methods of oocyte cryopreservation and evaluate their impact on reproductive outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Longer than P75 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
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 27, 2012
CompletedFirst Posted
Study publicly available on registry
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedSeptember 11, 2018
September 1, 2018
4.3 years
September 27, 2012
September 7, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
Oocyte cryopreservation
EXPERIMENTALInterventions
Oocyte (egg) cryopreservation (freezing) to preserve fertility
Eligibility Criteria
You may qualify if:
- Any consenting female who wishes to freeze unfertilized oocytes and are:
- at risk for ovarian hyperstimulation syndrome (enlarged ovaries with abdominal fluid accumulation) and postponement of pregnancy has been recommended.
- a cancer patient anticipating treatment and have been cleared by the oncologists for ovarian stimulation.
- a female who seeks to preserve her future fertility and does not wish to use donor or partner sperm to fertilize her eggs.
- 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.
- a patient for whom the partner's sperm retrieval or production has failed and donor sperm is not an option.
- 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
- has been clinically and psychologically approved for ovarian stimulation
- age between 12 and 42 years, inclusive, at time of informed consent.
- willing and able to comply with the protocol.
- willing to provide follow-up information from her OB/GYN of any CVS/amniocentesis results, as well as information on obstetrical outcome.
- agree to undergo intracytoplasmic sperm injection (ICSI) when oocytes are thawed.
- For cancer patients:
- No significant ovarian pathology as judged by physical exam and radiological studies;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medical College
New York, New York, 10021, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2012
First Posted
October 1, 2012
Study Start
June 1, 2009
Primary Completion
October 1, 2013
Study Completion
October 1, 2017
Last Updated
September 11, 2018
Record last verified: 2018-09