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OpenTrials
Completed

NCT Number: NCT01422395

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

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.

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Key information

Conditions

Fertility

Age range

21 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Main Line Fertility Center

Bryn Mawr, Pennsylvania, 19010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Freezing

Procedure

Vitrification

Primary outcomes

  1. fertilization rate

    Time frame: 18 hours after insemination

  2. Embryo Quality

    Time frame: day 3 and day 5

  3. Embryo Development

    Time frame: Day 3 and day 5

Sponsors and collaborators

Lead sponsor

Main Line Fertility Center

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 24, 2011
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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