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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


Phase 0
21 Years
37 Years
Open (Enrolling)
Female
Fertility

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

fertilization rate

Outcome Time Frame:

18 hours after insemination

Safety Issue:

No

Principal Investigator

Glassner J Michael, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Main Line Fertility Center

Authority:

United States: Food and Drug Administration

Study ID:

MLFC-001

NCT ID:

NCT01422395

Start Date:

August 2011

Completion Date:

October 2012

Related Keywords:

  • Fertility
  • Vitrification
  • Egg Freezing
  • Oocyte Cryopreservation

Name

Location
Main Line Fertility Center Bryn Mawr, Pennsylvania  19010