Oocyte Cryopreservation

NCT ID: NCT01696786

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2017-10-31

Brief Summary

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

Conditions

Fertility Preservation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oocyte cryopreservation

Group Type: EXPERIMENTAL

Oocyte cryopreservation

Intervention Type: PROCEDURE

Oocyte (egg) cryopreservation (freezing) to preserve fertility

Interventions

Oocyte cryopreservation

Oocyte (egg) cryopreservation (freezing) to preserve fertility

Intervention Type: PROCEDURE

Eligibility 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.

• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Weill Cornell Medical College

New York, New York, United States

Countries

United States

Other Identifiers

0903010292

Identifier Type: -

Identifier Source: org_study_id