Comparison of Transfers of Fresh and Thawed Embryos in Patients With Prior Failed Embryo Transfer Cycles
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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 |
- Ongoing pregnancy with fetal heart motion [ Time Frame: 10 weeks gestation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| 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 |
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| United States, Nevada | |
| Fertility Center of Las Vegas | |
| Las Vegas, Nevada, United States, 89117 | |
| 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: | February 5, 2009 |
| 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 May 22, 2013