Oocyte Cryopreservation

Fertility Preservation Clinical Trial

Official title:

Oocyte Cryopreservation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696786
• Other study ID #: 0903010292
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: October 2017

Study information

• Verified date: September 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2017
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fertility Preservation

Intervention

Procedure:
• Oocyte cryopreservation
Oocyte (egg) cryopreservation (freezing) to preserve fertility

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate of cryopreserved oocytes with each cryopreservation method	Survival rate of cryopreserved oocytes with each cryopreservation method	1 year
Primary	Pregnancy rate following thawing/warming of oocytes	Pregnancy rate following thawing/warming of oocytes	1 year
Primary	Implantation rate per embryo transferred	Implantation rate per embryo transferred	1 year