Evaluation of the Impact of Vitrification on Oocytes

Not Applicable

Completed

• Conditions: Fertilization
• Interventions: Procedure: Vitrification and PGD

• Registration Number: NCT01223118
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief 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.

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).

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oocyte Vitrification	Vitrification and PGD	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.

Primary Outcome Measures

Name	Time	Method
Aneuploidy Rate (evaluation of whether embryo is chromosomally normal)	1 year	Compare the rate of chromosomally-abnormal embryos among embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.

Secondary Outcome Measures

Name	Time	Method
Delivery rates	1 year	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)	1 year	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.

Trial Locations

Locations (2)

Reproductive Medicine Assoicates of PA at Lehigh Valley; 🇺🇸 Allentown, Pennsylvania, United States

Reproductive Medicine Associates of New Jersey; 🇺🇸 Morristown, New Jersey, United States