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NCT Number: NCT00839839

Egg Freezing Pilot Study

University Reproductive Associates is conducting a pilot study to study the technique of egg freezing. Your participation in this study will provide us with important information to allow us to offer this technology for women wishing to freeze their eggs before cancer treatments. Your participation will include a standard IVF cycle with your eggs being frozen for a brief period of time and then transferred back to you as usual. You will receive a significant reduction in your IVF cycle cost.

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Key information

Conditions

Infertility Egg Freezing Genital Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Reproductive Associates

Hasbrouck Heights, New Jersey, 07604, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form.
  • In good general health off of current medications which may confound response to study medications.
  • Desire to seek pregnancy actively during the study period by IVF-ICSI.
  • A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
  • Ability to use the required medications.
  • Day 3 FSH level < 12 IU/ml

Exclusion criteria

  • Current pregnancy
  • Patients with significant anemia (Hemoglobin < 10 mg/dL).
  • Patients enrolled simultaneously into other investigative studies that would interfere with this research study.

Treatment and study plan

oocyte vitrification

Procedure

All oocytes retrieved will be vitrified (rapidly frozen) after egg retrieval. The oocytes will then be warmed on the same day and fertilized per standard IVF-ICSI. Resulting embryos will be transferred back to the patient as per protocol.

Primary outcomes

  1. Incidence of Biochemical Pregnancy

    Time frame: 1 year

Secondary outcomes

  1. Recovery of viable oocytes

    Time frame: 1 year

  2. incidence of fertilization

    Time frame: one year

  3. embryo development (how many fertilized eggs undergo development to a more advanced stage)

    Time frame: 1 year

  4. clinical pregnancy (fetal pole visible on transvaginal ultrasound) per cycle

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Reproductive Associates

Other

Registry information

Official study title

Oocyte Cryopreservation in Assisted Reproduction

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Feb 10, 2009
Registry last updated
Dec 3, 2015

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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