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Comparison of Transfers of Fresh and Thawed Embryos in Patients With Prior Failed Embryo Transfer Cycles

Primary Purpose

Infertility, Subfertility

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embryo cryopreservation
Fresh embryo transfer
Sponsored by
Fertility Center of Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF, blastocyst transfer, endometrium, embryo cryopreservation

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 to 40 years
  • Cycle day 3 FSH less than 10 IU/l
  • At least 8 antral follicles
  • At least one previous autologous embryo transfer cycle that did not result in ongoing pregnancy at 10 weeks.

Exclusion Criteria:

  • Embryo biopsy
  • Any prior fresh embryo transfer that resulted in live birth

Sites / Locations

  • Fertility Center of Las Vegas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Test group

Arm Description

Patients in the control group will undergo conventional IVF cycles with fresh blastocyst transfer.

Patients in the Test group will have their embryos cryopreserved for transfer in a second cycle.

Outcomes

Primary Outcome Measures

Ongoing pregnancy with fetal heart motion

Secondary Outcome Measures

Full Information

First Posted
August 13, 2008
Last Updated
April 8, 2014
Sponsor
Fertility Center of Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT00736177
Brief Title
Comparison of Transfers of Fresh and Thawed Embryos in Patients With Prior Failed Embryo Transfer Cycles
Official Title
Comparison of Transfers of Fresh and Thawed Embryos in Patients With Prior Failed Embryo Transfer Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Withdrawn
Why Stopped
No recruitment
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fertility Center of Las Vegas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study seeks to determine if patients with a history of failed fresh embryo transfer(s) will have increased success rates with embryo cryopreservation and subsequent thawed embryo transfer when compared to fresh embryo transfer.
Detailed Description
Implantation failure remains a significant problem in cycles of in vitro fertilization (IVF). Patients with a history of implantation failure in fresh autologous cycles have been shown have reduced chance of success in subsequent fresh autologous cycles. A potentially frequent cause of implantation failure is reduced endometrial receptivity following ovarian stimulation, perhaps due to the effects of supraphysiologic hormone levels on endometrial development. Therefore, such patients may have a greater chance of success if all of their embryos are cryopreserved for use in a subsequent cycle in which endometrial development can be more carefully controlled, absent the effects of ovarian stimulation. Therefore this study compares success rates in cycles of fresh embryo transfer and cycles with transfer of frozen-thawed embryos.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Subfertility
Keywords
IVF, blastocyst transfer, endometrium, embryo cryopreservation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in the control group will undergo conventional IVF cycles with fresh blastocyst transfer.
Arm Title
Test group
Arm Type
Experimental
Arm Description
Patients in the Test group will have their embryos cryopreserved for transfer in a second cycle.
Intervention Type
Procedure
Intervention Name(s)
Embryo cryopreservation
Intervention Description
Subjects in the Test group will have their embryos cryopreserved for transfer in a subsequent cycle.
Intervention Type
Procedure
Intervention Name(s)
Fresh embryo transfer
Intervention Description
Subjects in the Control group will receive fresh embryo transfer.
Primary Outcome Measure Information:
Title
Ongoing pregnancy with fetal heart motion
Time Frame
10 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 to 40 years Cycle day 3 FSH less than 10 IU/l At least 8 antral follicles At least one previous autologous embryo transfer cycle that did not result in ongoing pregnancy at 10 weeks. Exclusion Criteria: Embryo biopsy Any prior fresh embryo transfer that resulted in live birth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Shapiro, M.D.
Organizational Affiliation
Fertility Center of Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Center of Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17905239
Citation
Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Thomas S. Large blastocyst diameter, early blastulation, and low preovulatory serum progesterone are dominant predictors of clinical pregnancy in fresh autologous cycles. Fertil Steril. 2008 Aug;90(2):302-9. doi: 10.1016/j.fertnstert.2007.06.062. Epub 2007 Oct 1.
Results Reference
background
PubMed Identifier
17224151
Citation
Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Ross R. Contrasting patterns in in vitro fertilization pregnancy rates among fresh autologous, fresh oocyte donor, and cryopreserved cycles with the use of day 5 or day 6 blastocysts may reflect differences in embryo-endometrium synchrony. Fertil Steril. 2008 Jan;89(1):20-6. doi: 10.1016/j.fertnstert.2006.08.092. Epub 2007 Jan 16.
Results Reference
background
Links:
URL
http://www.fertilitycenterlv.com
Description
Fertility Center of Las Vegas

Learn more about this trial

Comparison of Transfers of Fresh and Thawed Embryos in Patients With Prior Failed Embryo Transfer Cycles

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