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

This study has been withdrawn prior to enrollment.
(No recruitment)
Sponsor:
Information provided by:
Fertility Center of Las Vegas
ClinicalTrials.gov Identifier:
NCT00736177
First received: August 13, 2008
Last updated: April 8, 2014
Last verified: February 2009
  Purpose

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.


Condition Intervention
Infertility
Subfertility
Procedure: Embryo cryopreservation
Procedure: Fresh embryo transfer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Transfers of Fresh and Thawed Embryos in Patients With Prior Failed Embryo Transfer Cycles

Resource links provided by NLM:


Further study details as provided by Fertility Center of Las Vegas:

Primary Outcome Measures:
  • Ongoing pregnancy with fetal heart motion [ Time Frame: 10 weeks gestation ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Patients in the control group will undergo conventional IVF cycles with fresh blastocyst transfer.
Procedure: Fresh embryo transfer
Subjects in the Control group will receive fresh embryo transfer.
Experimental: Test group
Patients in the Test group will have their embryos cryopreserved for transfer in a second cycle.
Procedure: Embryo cryopreservation
Subjects in the Test group will have their embryos cryopreserved for transfer in a subsequent cycle.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736177

Locations
United States, Nevada
Fertility Center of Las Vegas
Las Vegas, Nevada, United States, 89117
Sponsors and Collaborators
Fertility Center of Las Vegas
Investigators
Principal Investigator: Bruce Shapiro, M.D. Fertility Center of Las Vegas
  More Information

Additional Information:
Publications:
Responsible Party: Bruce Shapiro, M.D., Medical Director, Fertility Center of Las Vegas
ClinicalTrials.gov Identifier: NCT00736177     History of Changes
Other Study ID Numbers: SAIRB-08-0012
Study First Received: August 13, 2008
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fertility Center of Las Vegas:
IVF
blastocyst transfer
endometrium
embryo cryopreservation

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014