ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01448460
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
Greg L. Christensen, University of Louisville

Brief Summary:
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.

Condition or disease
Fertility Preservation

Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oocyte Vitrification for IVF Patients and Women With Fertility Threatening Conditions
Study Start Date : September 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Group/Cohort
Fertility Patients
IVF patients with extra eggs or other subjects who desire egg vitrification for fertility preservation



Biospecimen Description:
oocytes


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 42 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
IVF patients who desire to have extra eggs, in excess of what is needed for their IVF cycle, or subjects requesting fertility preservation due to fertility threatening conditions such as cancer, advanced age or other.
Criteria

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.

Responsible Party: Greg L. Christensen, IVF Lab Director, University of Louisville
ClinicalTrials.gov Identifier: NCT01448460     History of Changes
Other Study ID Numbers: 09.356
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013