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Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Main Line Fertility Center
ClinicalTrials.gov Identifier:
NCT01422395
First received: August 22, 2011
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Fertility
Procedure: Freezing
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Main Line Fertility Center:

Primary Outcome Measures:
  • fertilization rate [ Time Frame: 18 hours after insemination ] [ Designated as safety issue: No ]
  • Embryo Quality [ Time Frame: day 3 and day 5 ] [ Designated as safety issue: No ]
  • Embryo Development [ Time Frame: Day 3 and day 5 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: freezing Procedure: Freezing
Vitrification
No Intervention: No freezing

  Eligibility

Ages Eligible for Study:   21 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Smokers
  • Polycystic Ovarian Syndrome (PCO)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422395

Locations
United States, Pennsylvania
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States, 19010
Sponsors and Collaborators
Main Line Fertility Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Glassner J Michael, M.D. Main Line Fertility Center
Study Director: Sharon H. Anderson, Ph.D Main Line Fertility Center
  More Information

No publications provided

Responsible Party: Main Line Fertility Center
ClinicalTrials.gov Identifier: NCT01422395     History of Changes
Other Study ID Numbers: MLFC-001
Study First Received: August 22, 2011
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Main Line Fertility Center:
Vitrification
Egg Freezing
Oocyte Cryopreservation

ClinicalTrials.gov processed this record on November 27, 2014