Clinical trial NCT00736177: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Infertility
Subfertility
Keywords: IVF
blastocyst transfer
endometrium
embryo cryopreservation
Lead sponsor: Fertility Center of Las Vegas
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ongoing pregnancy with fetal heart motion
timeFrame: 10 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Fertility Center of Las Vegas
state: Nevada
Study officials:
affiliation: Fertility Center of Las Vegas
name: Bruce Shapiro, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.