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Performance Study of New Media for Vitrification of Human Oocytes

This study is currently recruiting participants.
Verified May 2012 by Vitrolife
Sponsor:
Information provided by (Responsible Party):
Vitrolife
ClinicalTrials.gov Identifier:
NCT01481571
First received: November 18, 2011
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to evaluate safety and performance of Vitrolife´s new oocyte vitrification/warming media and the vitrification device Rapid-i™, when using vitrification as a cryopreservation method for human oocytes.


Condition Intervention
Infertility
 Device: Vitrification medium oocyte, warming medium oocyte and Rapid-i

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Performance Study of New Media for Vitrification of Human Oocytes

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Vitrolife:

Primary Outcome Measures:
  • Embryo development after oocyte vitrification/warming. [ Time Frame: 5 days after oocyte retrieval ] [ Designated as safety issue: No ]
    Embryo development, as number of good quality blastocysts, after oocyte vitrification and warming.


Secondary Outcome Measures:
  • Clinical parameters of previously vitrified/warmed oocytes. [ Time Frame: 40 weeks after implantation ] [ Designated as safety issue: No ]
    Assessment of implantation rate, miscarriage rate, pregnancy rate and neonatal outcome of previously vitrified/warmed oocytes.


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitrification media and device
Vitrification medium oocyte, warming medium oocyte and Rapid-i
 Device: Vitrification medium oocyte, warming medium oocyte and Rapid-i
Media and device for vitrification of human oocytes

Detailed Description:

A multi-center prospective sibling oocyte vitrification trial where, in the first phase, half of the patients' oocytes will be vitrified and warmed (experimental group). The remaining oocytes will not be vitrified and will serve as the control group. In the second phase all of the patients' oocytes will be vitrified and the embryo transfer will be performed in a following cycle. This simulates the situation of a normal cryopreservation embryo transfer. The study population consists of 20 women who will undergo a fresh IVF cycle during the study period. The primary objective in the first phase is to assess survival, fertilization and embryo development after oocyte vitrification/warming with the new media. The results will be compared with results from sibling oocytes which have not been vitrified. Secondary objectives are to assess the clinical results such as implantation, miscarriage and pregnancy rate as well as delivery rate and neonatal outcome.

The primary objective in the second phase is to assess the delivery rate after oocyte vitrification/warming with the new media. Secondary objectives are to assess survival, fertilization, embryo development, utilization rate, pregnancy rate and neonatal outcome on the previously vitrified and warmed oocytes. The results will be compared with results from a control group of patients, treated at the same clinics within the same time period, using the same inclusion and exclusion criteria. All patients who undergo embryo transfer will have a serum beta-hCG test conducted 14 days after oocyte retrieval. If positive, repeat beta-hCG testing will be conducted 2-4 days later. If appropriate, a pregnancy ultrasound will be conducted between 6-8 weeks gestation (menstrual age) to record gestational sac(s) and fetal heart beat. The delivery outcome will also be recorded. For patients with an unsuccessful treatment, there will be a follow-up period of 6 months after study completion. From this follow-up, data from frozen cycles, i.e. from embryos after oocyte vitrification, can be evaluated as well.

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Couple agreed to participate in study and has signed the Informed Consent Document before any study-related activities
  • Patient age (female): 18-37 years (including oocyte donors)
  • BMI 18-27 kg/m2 (female)
  • 2 ovaries, normal uterine cavity (female)
  • Day 3 FSH ≤ 10mIU, E2 <80 pg/mL and an AFC ≥12 (both ovaries, 3 mm or greater) (female)
  • AMH >1 (female)
  • Ejaculatory sperm (male)
  • ICSI fertilization
  • Long standard stimulation protocol
  • English speaking

Exclusion Criteria:

  • Previous participation in the study
  • ≥2 previous failed IVF cycles
  • Endometrioma
  • Presence of a hydrosalpinx
  • History of recurrent miscarriage (defined as ≥2 clinical recognized SABs)
  • Not willing to have ICSI performed
  • Cycle length >6 weeks [a diagnosis of PCOS will not exclude from the study unless typical cycle length is greater than 6 weeks; this criteria would exclude hypothalamic-hypogonadotropic patients]
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481571

Contacts
Contact: Marius Meintjes, Dr 972-377-2625 mmeintjes@friscoinfertility.com

Locations
United States, Texas
The DFW Fertility Associates, Reproductive Endocrinology and Infertility, Dallas Fertility Centre Recruiting
Dallas, Texas, United States, 75231
Contact: Samuel Chantilis, Dr         samuel.chantilis@dallasfertility.com    
Contact: Mark Larman, Dr         mlarman@vitrolife.com    
Principal Investigator: Samuel Chantilis, Dr            
Frisco IVF Recruiting
Frisco, Texas, United States, 75034
Contact: Marius Meintjes, Dr         mmeintjes@friscoinfertility.com    
Contact: Mark Larman         mlarman@vitrolife.com    
Principal Investigator: Marius Meintjes, Dr            
Sponsors and Collaborators
Vitrolife
Investigators
Principal Investigator: Marius Meintjes, Dr
  More Information

No publications provided

Responsible Party: Vitrolife
ClinicalTrials.gov Identifier: NCT01481571     History of Changes
Other Study ID Numbers: Vitrolife-oocyte-vitri 01
Study First Received: November 18, 2011
Last Updated: May 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vitrolife:
Media for vitrification/warming of human oocytes

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013