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

M

Main Line Fertility Center

Status and phase

Completed
Early Phase 1

Conditions

Fertility

Treatments

Procedure: Freezing

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01422395
MLFC-001

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Female

Ages

21 to 37 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

freezing
Experimental group
Treatment:
Procedure: Freezing
No freezing
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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