Oocyte Cryopreservation

Not Applicable

Completed

• Conditions: Fertility Preservation
• Interventions: Procedure: Oocyte cryopreservation

• Registration Number: NCT01696786
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-10-01
• Primary Completion: 2013-10
• Study Completion: 2017-10
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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.

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Exclusion Criteria

Age > 42 Subjects who do not meet the inclusion criteria will be ineligible for participation in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oocyte cryopreservation	Oocyte cryopreservation	-

Primary Outcome Measures

Name	Time	Method
Pregnancy rate following thawing/warming of oocytes	1 year	Pregnancy rate following thawing/warming of oocytes
Implantation rate per embryo transferred	1 year	Implantation rate per embryo transferred
Survival rate of cryopreserved oocytes with each cryopreservation method	1 year	Survival rate of cryopreserved oocytes with each cryopreservation method

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States