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

Early Phase 1

Completed

• Conditions: Fertility
• Interventions: Procedure: Freezing

• Registration Number: NCT01422395
• Lead Sponsor: Main Line Fertility Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
freezing	Freezing	-

Primary Outcome Measures

Name	Time	Method
fertilization rate	18 hours after insemination
Embryo Quality	day 3 and day 5
Embryo Development	Day 3 and day 5

Trial Locations

Locations (1)

Main Line Fertility Center; 🇺🇸 Bryn Mawr, Pennsylvania, United States