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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01422395

Enrollment

Registered

2011-08-24

Start date

2011-08-31

Completion date

2013-05-31

Last updated

2014-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility

Keywords

Vitrification, Egg Freezing, Oocyte Cryopreservation

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.

Interventions

PROCEDUREFreezing

Vitrification

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 37 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
fertilization rate	18 hours after insemination
Embryo Quality	day 3 and day 5
Embryo Development	Day 3 and day 5

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026