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OpenTrials
Completed

NCT Number: NCT01696786

Oocyte Cryopreservation

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

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Key information

Age range

Up to 42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical College

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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;
  • Patient's general condition and prognosis deemed favorable for surgery and chemo/radio therapy;
  • No other major medical illness,
  • 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.

Treatment and study plan

Oocyte cryopreservation

Procedure

Oocyte (egg) cryopreservation (freezing) to preserve fertility

Primary outcomes

  1. Survival rate of cryopreserved oocytes with each cryopreservation method

    Time frame: 1 year

    Survival rate of cryopreserved oocytes with each cryopreservation method

  2. Pregnancy rate following thawing/warming of oocytes

    Time frame: 1 year

    Pregnancy rate following thawing/warming of oocytes

  3. Implantation rate per embryo transferred

    Time frame: 1 year

    Implantation rate per embryo transferred

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2017
First posted
Oct 1, 2012
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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