Evaluation of the Impact of Vitrification on Oocytes

NCT01223118 | Completed

• 1 other identifier: RMA-2010-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Fertilization

Keywords

Oocyte; vitrification; IVF; PGD; embryo biopsy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Delivery rates

  1 year

• Paired Sustained Implantation Rate (number of viable fetuses beyond the first trimester per embryo transferred)

  1 year

Study Arms (1)

Oocyte Vitrification

EXPERIMENTAL

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

Interventions

Vitrification and PGD PROCEDURE

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.

Also known as: Vitrification, PGD

Oocyte Vitrification

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• No prior failed IVF treatment cycle
• Female partner less than 35 years of age at time of onset of the IVF cycle
• Normal maximum prior day 3 follicle stimulating hormone (FSH) level (\< or = 10 IU/L)
• Total basal antral follicle count greater than or equal to 12
• 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
• Body Mass Index (BMI) ≤ 32 kg/m2

You may not qualify if:

• Diagnosis of chronic oligoovulation or anovulation (cycle typically occurring less often than every 38 days)
• Diagnosis of endometrial insufficiency
• Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)
• Use of testicular aspiration or biopsy procedures to obtain sperm
• Unevaluated ovarian mass
• Presence of hydrosalpinges which communicate with the endometrial cavity
• Any contraindication to undergoing in vitro fertilization or gonadotropin stimulation

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead

Study Sites (2)

Reproductive Medicine Associates of New Jersey

Morristown, New Jersey, 07960, United States

Location

Reproductive Medicine Assoicates of PA at Lehigh Valley

Allentown, Pennsylvania, 18104, United States

Location

MeSH Terms

Interventions

Vitrification; Prostaglandins D

Intervention Hierarchy (Ancestors)

Phase Transition; Physical Phenomena; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Richard T Scott, MD

  Reproductive Medicine Associates of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 18, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (2)