Evaluation of the Impact of Vitrification on Oocytes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT01223118
First received: October 8, 2010
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.


Condition Intervention
Fertilization
Procedure: Vitrification and PGD

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of the Impact of Vitrification on the Reproductive Performance and Potential of Human Oocytes

Further study details as provided by Reproductive Medicine Associates of New Jersey:

Primary Outcome Measures:
  • Aneuploidy Rate (evaluation of whether embryo is chromosomally normal) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Compare the rate of chromosomally-abnormal embryos among embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.


Secondary Outcome Measures:
  • Delivery rates [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    All embryos will be biopsied prior to transfer and DNA samples will be collected from all infants. Compare embryonic and infant DNA to evaluate whether the live birth resulted from a vitrified or a fresh/control oocyte.

  • Paired Sustained Implantation Rate (number of viable fetuses beyond the first trimester per embryo transferred) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Among patients with a paired two blastocyst transfer, compare the implantation rate of embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.


Enrollment: 120
Study Start Date: August 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oocyte Vitrification
Each patient will have oocytes randomized into two groups immediately after retrieval. Half of oocytes will be vitrified, thawed and inseminated. The other half will be inseminated only. All embryos will be biopsied for PGD prior to transfer and one embryo from each group will be transferred (vitrification and control groups). Following delivery, buccal swabs will be collected on all infants.
Procedure: Vitrification and PGD
Half of the oocytes retrieved from each patient will undergo vitrification, immediate thaw and insemination. All embryos will undergo biopsy for PGD prior to transfer.
Other Names:
  • Vitrification
  • PGD

Detailed Description:

This study will recruit patients from the NY/NJ/CT/eastern PA area only.

Cryopreservation of human oocytes has a great potential to preserve or extend fertility in the face of disease whose treatment would result in a loss of ovarian function. (malignancy, severe autoimmune disease, etc.). It would also provide a means of quarantining oocytes to be used in oocyte donation to provide the lowest possible risk of infection.

There are two methods for storage of oocytes: slow freezing or vitrification. Slow freezing is the conventional method and has been successfully used for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. However, the technique has not been rigorously validated to date. The aim of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.

Patients will undergo ovarian stimulation for in vitro fertilization (IVF) according to the protocol recommended by their primary doctor. After retrieval, mature oocytes will be divided in half. One half will undergo vitrification, immediate thaw and intracytoplasmic sperm injection (ICSI). The other half will undergo just ICSI. All embryos will then develop on identical culture until day 3 or day 5. Prior to transfer, the best embryo from each group will undergo biopsy for genetic fingerprinting. The patient will have a 2 embryo transfer (one from each group). All extra embryos will be biopsied for pre-implantation genetic diagnosis (PGD) prior to being cryopreserved. If the patient becomes pregnant, we will follow up with an additional blood draw at approximately 9 weeks gestation and buccal swabs after the delivery of the infant(s).

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

This study will recruit patients from the NY/NJ/CT/eastern PA area only.

Inclusion Criteria:

  1. No prior failed IVF treatment cycle
  2. Female partner less than 35 years of age at time of onset of the IVF cycle
  3. Normal maximum prior day 3 follicle stimulating hormone (FSH) level (< or = 10 IU/L)
  4. Total basal antral follicle count greater than or equal to 12
  5. Male partner with greater than 100,000 total motile spermatozoa Donor sperm is acceptable but the couples will be required to provide one additional vial for DNA analysis
  6. Body Mass Index (BMI) ≤ 32 kg/m2

Exclusion Criteria:

  1. Diagnosis of chronic oligoovulation or anovulation (cycle typically occurring less often than every 38 days)
  2. Diagnosis of endometrial insufficiency
  3. Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)
  4. Use of testicular aspiration or biopsy procedures to obtain sperm
  5. Unevaluated ovarian mass
  6. Presence of hydrosalpinges which communicate with the endometrial cavity
  7. Any contraindication to undergoing in vitro fertilization or gonadotropin stimulation
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223118

Locations
United States, New Jersey
Reproductive Medicine Associates of New Jersey
Morristown, New Jersey, United States, 07960
United States, Pennsylvania
Reproductive Medicine Assoicates of PA at Lehigh Valley
Allentown, Pennsylvania, United States, 18104
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Richard T Scott, MD Reproductive Medicine Associates of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01223118     History of Changes
Other Study ID Numbers: RMA-2010-02
Study First Received: October 8, 2010
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Reproductive Medicine Associates of New Jersey:
Oocyte
vitrification
IVF
PGD
embryo biopsy

ClinicalTrials.gov processed this record on August 28, 2014