OHSU

IRB #

IRB00006709

Title

[STEM CELLS] Mitochondrial gene replacement in human oocytes

Principal Investigator

Shoukhrat Mitalipov

Study Purpose

The purpose of this study is to evaluate new techniques for correcting mitochondrial gene mutations in human eggs.

Medical Condition(s)

Mitchondrial DNA (mtDNA) mutations

Eligibility Criteria

Women between 21 and 35 years of age may be eligible if they are:

-In good general health OR have been diagnosed as a carrier of a mtDNA mutation or have at least one child (living or deceased) diagnosed with an inherited mtDNA disease
-Not pregnant
-Have regular menstrual cycles
-Interested in donating oocytes (egg cells), blood and a skin cell samples (for patients diagnosed with a mtDNA mutation disorder) for research

Age Range

21 - 60

Healthy Volunteers Needed

Yes

Duration of Participation

Active study participation will last approximately two months (about two menstrual cycles).

Interested candidates will be required to undergo medical, physiological and psychological screening to determine their eligibility. Participants will be required to take hormones to stimulate the development of egg cells (oocytes), and the oocyte retrieval procedure will be performed by physicians at the OHSU Department of Reproductive Endocrinology in Portland, Oregon. Patients diagnosed with a mtDNA mutation disorder will also be required to donate a 1-3 mm biopsy of skin from their arm.

There are risks involved with these procedures. Researchers will review all potential risks and side effects with potential subjects before they begin any study procedures.

Minors Included

No

Contact

Women's Health Research Unit Confidential Recruitment Line: 503.494.3666

Sponsor

OHSU Circle of Giving

Recruitment End

09/01/2015

Compensation Provided

Yes

Compensation

Upon full completion of this study, subjects will be paid $5000 for egg donation and $50 for skin donation (for mtDNA mutation patients only) as compensation for time and costs related to this study. If the study subject stops participating before completing all visits, a pro-rated portion of this amount will be paid, based on the number of visits completed.


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