Oocyte Vitrification for In Vitro Fertilization (IVF) Patients and Women With Fertility Threatening Conditions



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:September 2009
Contact:Greg L Christensen, Ph.D.
Email:gregchristensen.phd@gmail.com
Phone:502-271-5845

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Oocyte Vitrification for IVF Patients and Women With Fertility Threatening Conditions


Vitrification is a method of cryopreserving tissue for future use. It is widely used to
preserve extra, good quality embryos generated from infertility treatments. It is becoming
popular for the preservation of oocytes (eggs) as well, but is still considered
investigational in this respect. The purpose of this study is to provide egg freezing for
patients desiring fertility preservation. Although commonly used in clinics around the
world, it should be offered as an IRB approved study procedure until it is no longer
considered investigational by the American Society of Reproductive Medicine.


Inclusion Criteria:

- Women between the ages of 18 and 37 and who require IVF for a successful pregnancy
will be approached to consent for the study,. They must also have a cycle day 3 FSH
< 10 mIU/ml, estradiol < 70 pg/ml and a baseline follicle count > 10. The BMI must be
between 20 and 32kg/m2. If they do consent, eggs will only be vitrified if 13 or
more mature metaphase II oocytes are collected.

- Women between the ages of 14 and 42 who are seeking treatment for fertility
preservation. In addition they must also meet the following criteria.

- Patient is willing and able to delay any relevant therapy for up to 40 days.

- Have functioning ovaries as determined by blood / ultrasound testing.

- Patient is willing to undergo infectious disease testing for HIV, hepatitis B and C,
syphilis, gonorrhea and Chlamydia.

- The patient must have clearance from their oncologist or medical specialist, if any,
to undergo ovarian stimulation and transvaginal oocyte retrieval.

- The patient must not have a past history of blood clots in the veins or in the lungs.

- The patient must be willing to undergo transvaginal, internal ultrasound examination
and pelvic examination.

Exclusion Criteria:

- Patients with a cycle day 3 FSH > 10 mIU/ml, cycle day 3 estradiol > 70 pg/ml and a
baseline follicle count < 10 will be excluded.

- Patients with a BMI <20 and >32 will be excluded.

- Patients who are not willing or are unable to meet the above mentioned eligibility
requirments.

- Patients with expected low ovarian reserve [evaluated on day 3 by an antral follicle
count of <3 follicles at 2-5 mm diameter and/or an increased concentration of
follicle stimulating hormone (FSH) >15 IU [15] on cycle day 3 ].

- Patients with possible poor quality of oocytes, based on medical history including
previous exposure to chemotherapeutics or radiation.
We found this trial at
1
site
Louisville, Kentucky 40202
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from
Louisville, KY
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