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Day of Embryo Transfer for Patients Undergoing In Vitro Fertilization

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Day 3 embryo transfer
Day 2 embryo transfer
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Day 2 embryo transfer

Day 3 embryo transfer

Arm Description

Embryos are transferred 2 days after fertilization.

Standard of care for women undergoing IVF with a limited number of embryos is to transfer all embryos on Day 3 after fertilization

Outcomes

Primary Outcome Measures

Pregnancy rates

Secondary Outcome Measures

Live birth rates
Multiple gestation rates

Full Information

First Posted
February 1, 2008
Last Updated
November 23, 2016
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00615771
Brief Title
Day of Embryo Transfer for Patients Undergoing In Vitro Fertilization
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Day 2 embryo transfer
Arm Type
Experimental
Arm Description
Embryos are transferred 2 days after fertilization.
Arm Title
Day 3 embryo transfer
Arm Type
Active Comparator
Arm Description
Standard of care for women undergoing IVF with a limited number of embryos is to transfer all embryos on Day 3 after fertilization
Intervention Type
Procedure
Intervention Name(s)
Day 3 embryo transfer
Intervention Description
Standard of care
Intervention Type
Procedure
Intervention Name(s)
Day 2 embryo transfer
Intervention Description
Embryos are transferred 1 day prior to standard of care
Primary Outcome Measure Information:
Title
Pregnancy rates
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Live birth rates
Time Frame
1 year
Title
Multiple gestation rates
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora K Shahine
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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