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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01422395
First Posted: August 24, 2011
Last Update Posted: June 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Main Line Fertility Center
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 ]
  • Embryo Quality [ Time Frame: day 3 and day 5 ]
  • Embryo Development [ Time Frame: Day 3 and day 5 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 37 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Main Line Fertility Center
ClinicalTrials.gov Identifier: NCT01422395     History of Changes
Other Study ID Numbers: MLFC-001
First Submitted: August 22, 2011
First Posted: August 24, 2011
Last Update Posted: June 4, 2014
Last Verified: June 2014

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