Egg Freezing Pilot Study

NCT ID: NCT00839839

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility Egg Freezing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oocyte Vitrification

Group Type EXPERIMENTAL

Oocyte Vitrification

Intervention Type 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.

Interventions

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Oocyte Vitrification

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form.
2. In good general health off of current medications which may confound response to study medications.
3. Desire to seek pregnancy actively during the study period by IVF-ICSI.
4. A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
5. Ability to use the required medications.
6. Day 3 FSH level \< 12 IU/ml

Exclusion Criteria

1. Current pregnancy
2. Patients with significant anemia (Hemoglobin \< 10 mg/dL).
3. Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Reproductive Associates

OTHER

Sponsor Role lead

Responsible Party

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Peter McGovern, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter G. McGovern, MD

Role: PRINCIPAL_INVESTIGATOR

UMDNJ-NJMS

Locations

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University Reproductive Associates

Hasbrouck Heights, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IRB 0120080226

Identifier Type: -

Identifier Source: org_study_id