Performance Study of New Media for Vitrification of Human Oocytes
1 other identifier
interventional
17
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedMarch 24, 2014
February 1, 2014
7 months
November 18, 2011
February 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Embryo development after oocyte vitrification/warming.
Embryo development, as number of good quality blastocysts, after oocyte vitrification and warming.
5 days after oocyte retrieval
Secondary Outcomes (3)
Implantation rate of previously vitrified/warmed oocytes.
4 weeks after embryo transfer
Ongoing pregnancy rate
3 months after embryo transfer
Live birth
9 months after embryo transfer
Study Arms (1)
Vitrification media and device
EXPERIMENTALVitrification medium oocyte, warming medium oocyte and Rapid-i
Interventions
Media and device for vitrification of human oocytes
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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 \[a diagnosis of PCOS will not exclude from the study unless typical cycle length is greater than 6 weeks; this criteria would exclude hypothalamic-hypogonadotropic patients\]
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vitrolifelead
Study Sites (2)
The DFW Fertility Associates, Reproductive Endocrinology and Infertility, Dallas Fertility Centre
Dallas, Texas, 75231, United States
Frisco IVF
Frisco, Texas, 75034, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marius Meintjes, Dr
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2011
First Posted
November 29, 2011
Study Start
January 1, 2012
Primary Completion
August 1, 2012
Study Completion
September 1, 2012
Last Updated
March 24, 2014
Record last verified: 2014-02