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Day of Embryo Transfer for Patients Undergoing In Vitro Fertilization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00615771
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Ruth Bunker Lathi, Stanford University

Tracking Information
First Submitted Date  ICMJE February 1, 2008
First Posted Date  ICMJE February 14, 2008
Last Update Posted Date November 28, 2016
Study Start Date  ICMJE January 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2011)
Pregnancy rates [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
Pregnancy rates
Change History Complete list of historical versions of study NCT00615771 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2011)
  • Live birth rates [ Time Frame: 1 year ]
  • Multiple gestation rates [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
  • Live birth rates
  • Multiple gestation rates
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Day of Embryo Transfer for Patients Undergoing In Vitro Fertilization
Official Title  ICMJE Embryo Transfer on Day 2 vs. Day 3 After Oocyte Retrieval in Patients Who Plan to Replace All Embryos After an In Vitro Fertilization Cycle
Brief Summary We are examining whether pregnancy rates differ based on day of embryo transfer in patients who replace all available embryos after an In vitro Fertilization (IVF) cycle. Patients must be undergoing IVF treatment at Stanford University and patients will not receive compensation for their participation (no medical costs covered or patient payment for participation).
Detailed Description The decision on the number of embryos to transfer after an IVF cycle is based on the number of available embryos, the quality of the embryos, the patient's age, and the goal of limiting multiple gestations. Stanford Fertility Center and most IVF centers examine the embryos on the third day after oocyte (egg) retrieval to select for the best quality embryos to transfer, and depending on quality, the remaining embryos are frozen to be used in the future. Patients with a limited number of embryos, those that plan to replace all available embryos after an IVF cycle, do not need to wait until the third day after oocyte retrieval to select embryos, and may replace the embryos on the second day after the oocyte retrieval. We are examining whether pregnancy rates differ among these patients based on the day of embryo transfer (Day 2 vs. Day3). Patients must be undergoing IVF treatment at Stanford University and patients will not receive compensation for their participation (no medical costs covered or patient payment for participation).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Procedure: Day 3 embryo transfer
    Standard of care
  • Procedure: Day 2 embryo transfer
    Embryos are transferred 1 day prior to standard of care
Study Arms  ICMJE
  • Experimental: Day 2 embryo transfer
    Embryos are transferred 2 days after fertilization.
    Intervention: Procedure: Day 2 embryo transfer
  • Active Comparator: Day 3 embryo transfer
    Standard of care for women undergoing IVF with a limited number of embryos is to transfer all embryos on Day 3 after fertilization
    Intervention: Procedure: Day 3 embryo transfer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2008)
242
Original Enrollment  ICMJE
 (submitted: February 1, 2008)
100
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients undergoing fresh IVF cycle at Stanford Fertility Center who plan on replacing all available embryos.

Exclusion Criteria:

Patients that do not meet above criteria.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00615771
Other Study ID Numbers  ICMJE SU-01312008-991
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ruth Bunker Lathi, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lora K Shahine Stanford University
PRS Account Stanford University
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP