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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00736177
• Other study ID #: SAIRB-08-0012
• Status: Withdrawn
• Phase: N/A
• First received: August 13, 2008
• Last updated: April 8, 2014
• Start date: August 2008
• Est. completion date: August 2009

Study information

• Verified date: February 2009
• Source: Fertility Center of Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Subfertility

Intervention

Procedure:
• Embryo cryopreservation
Subjects in the Test group will have their embryos cryopreserved for transfer in a subsequent cycle.
• Fresh embryo transfer
Subjects in the Control group will receive fresh embryo transfer.

Locations

Country	Name	City	State
United States	Fertility Center of Las Vegas	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Fertility Center of Las Vegas

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2007 Jan 16. — View 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. Epub 2007 Oct 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy with fetal heart motion		10 weeks gestation	No

External Links

•   Fertility Center of Las Vegas