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

Fertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422395
• Other study ID #: MLFC-001
• Status: Completed
• Phase: Phase 0
• First received: August 22, 2011
• Last updated: June 3, 2014
• Start date: August 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: Main Line Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 37 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fertility

Intervention

Procedure:
• Freezing
Vitrification

Locations

Country	Name	City	State
United States	Main Line Fertility Center	Bryn Mawr	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Main Line Fertility Center	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fertilization rate		18 hours after insemination	No
Primary	Embryo Quality		day 3 and day 5	No
Primary	Embryo Development		Day 3 and day 5	No