Evaluation of the Impact of Vitrification on Oocytes

Fertilization Clinical Trial

Official title:

Evaluation of the Impact of Vitrification on the Reproductive Performance and Potential of Human Oocytes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223118
• Other study ID #: RMA-2010-02
• Status: Completed
• Phase: N/A
• First received: October 8, 2010
• Last updated: January 22, 2013
• Start date: August 2010
• Est. completion date: July 2012

Study information

• Verified date: January 2013
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fertilization

Intervention

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.

Locations

Country	Name	City	State
United States	Reproductive Medicine Assoicates of PA at Lehigh Valley	Allentown	Pennsylvania
United States	Reproductive Medicine Associates of New Jersey	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aneuploidy Rate (evaluation of whether embryo is chromosomally normal)	Compare the rate of chromosomally-abnormal embryos among embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.	1 year	Yes
Secondary	Delivery rates	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.	1 year	Yes
Secondary	Paired Sustained Implantation Rate (number of viable fetuses beyond the first trimester per embryo transferred)	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.	1 year	No

External Links

•   Reproductive Medicine Associates of New Jersey