Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development
A Study to Compare Vitrified/Warmed Oocytes vs. Fresh Sibling Oocytes Collected Following Controlled Ovarian Stimulation Using Follistim AQ and Ganirelix Acetate on Fertilization Rates, Zygote Quality, Embryo Quality and Embryo Development
1 other identifier
interventional
40
1 country
1
Brief Summary
Indications for oocyte (egg) vitrification (fast freezing) include the preservation of reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation could allow women to delay childbearing if they want or need to. Until recently, conventional cryopreservation protocols have remained too inefficient for practical application in an infertility center. Very little is known about the effects of vitrification on oocytes and subsequent embryo development, especially using the sibling model (group of oocytes from the same cohort of ovarian follicles within patient). The purpose of this study is to examine the effect of oocyte vitrification on fertilization rates, embryo quality and development.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Aug 2011
1 active site
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
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 22, 2011
CompletedFirst Posted
Study publicly available on registry
August 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJune 4, 2014
June 1, 2014
1.8 years
August 22, 2011
June 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
fertilization rate
18 hours after insemination
Embryo Quality
day 3 and day 5
Embryo Development
Day 3 and day 5
Study Arms (2)
freezing
EXPERIMENTALNo freezing
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- healthy women ages 21-37 (inclusive)undergoing IVF in an attempt to achieve pregnancy
- Day 2-4 FSH \< 10 IU/ml, LH \<12 IU/ml, and E2 \<50 pg/ml
- Antimullerian Hormone (AMH) \>1.5
- Between 5 and 20 basal antral follicles on day 2-4 of the menstrual cycle
- BMI \>18 and \<32
You may not qualify if:
- Smokers
- Polycystic Ovarian Syndrome (PCO)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Main Line Fertility Centerlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Main Line Fertility Center
Bryn Mawr, Pennsylvania, 19010, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glassner J Michael, M.D.
Main Line Fertility Center
- STUDY DIRECTOR
Sharon H. Anderson, Ph.D
Main Line Fertility Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2011
First Posted
August 24, 2011
Study Start
August 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
June 4, 2014
Record last verified: 2014-06